Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3000239727
Manufacturer Name: Acumen Surgical (Pvt) Ltd.
Manufacturer address line 1: P.O. Box 1459
Manufacturer address line 2: Mubarik Pura
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--AZ
Importers product description: DENTAL HAND TOOLS(FOR EXPORT ONLY)
Refusal date: 10-MAR-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0063805-2/1/1/
Carrier: BRITISH AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3006661230
Manufacturer Name: Prais' Reliable Dental Supplies
Manufacturer address line 1: 310 Premier Building
Manufacturer address line 2:
Manufacturer City: Riga
Manufacturer Province/state:
Manufacturer Country: Latvia
Product code: 76E--BF
Importers product description: FILTEK Z250
Refusal date: 10-MAR-2008
FDA_District: BLT-DO
Entry/doc/line/sfx: DE8-0808872-3/2/1/
Carrier: KALITTA AIR, LLC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006661230
Manufacturer Name: Prais' Reliable Dental Supplies
Manufacturer address line 1: 310 Premier Building
Manufacturer address line 2:
Manufacturer City: Riga
Manufacturer Province/state:
Manufacturer Country: Latvia
Product code: 76E--BG
Importers product description: LUXATEMP PLUS
Refusal date: 10-MAR-2008
FDA_District: BLT-DO
Entry/doc/line/sfx: DE8-0808872-3/1/1/
Carrier: KALITTA AIR, LLC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3005835140
Manufacturer Name: Daiso Industries Co., Ltd.
Manufacturer address line 1: 1-4-14, Higashi Yoshiyuki Saijyo
Manufacturer address line 2:
Manufacturer City: Higashihiroshima
Manufacturer Province/state:
Manufacturer Country: Japan
Product code: 76E--FW
Importers product description: INTERDENT BRUSH
Refusal date: 03-MAR-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: ANP-0008987-1/146/1/
Carrier: NYK LINE (NIPPON YUSEN KAISHA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3005835140
Manufacturer Name: Daiso Industries Co., Ltd.
Manufacturer address line 1: 1-4-14, Higashi Yoshiyuki Saijyo
Manufacturer address line 2:
Manufacturer City: Higashihiroshima
Manufacturer Province/state:
Manufacturer Country: Japan
Product code: 76E--FW
Importers product description: DENTAL ERASER AND TOOTHBRUSHES LINE 352
Refusal date: 03-MAR-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: ANP-0008993-9/353/1/
Carrier: NYK LINE (NIPPON YUSEN KAISHA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006671641
Manufacturer Name: Shantou Chaonan Taimei Industry Co., Ltd.
Manufacturer address line 1: Dongmen, Xiangang, Simapu
Manufacturer address line 2: Chaonan District
Manufacturer City: Shantou City
Manufacturer Province/state: Guangdong
Manufacturer Country: China
Product code: 76E--FW
Importers product description: TOOTHBRUSH, MANUAL
Refusal date: 04-MAR-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 424-0151435-3/7/1/
Carrier: COMPAGNIE MARITIME D'AFFRETEM
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3006658787
Manufacturer Name: Futurepath Limited
Manufacturer address line 1: Room 1201 12/F Kelly Commercialcenter,
Manufacturer address line 2:
Manufacturer City: Kowloon
Manufacturer Province/state:
Manufacturer Country: Hong Kong SAR
Product code: 76E--FW
Importers product description: PACK LITE TOOTHBRUSH
Refusal date: 13-MAR-2008
FDA_District: MIN-DO
Entry/doc/line/sfx: 144-9148139-8/1/1/
Carrier: CHINA SHIPPING CONTAINER LINE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005215832
Manufacturer Name: Shenzhen Benliu Import And Export Co., Ltd.
Manufacturer address line 1: 15 Dong 3 District Qiao Dong 4f No.
Manufacturer address line 2:
Manufacturer City: Yiwu
Manufacturer Province/state:
Manufacturer Country: China
Product code: 76E--FW
Importers product description: TOOTHBRUSH
Refusal date: 19-MAR-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: GJ8-0047833-2/9/1/
Carrier: MSC-MEDITERRANEAN SHIPPING CO
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3000239727
Manufacturer Name: Acumen Surgical (Pvt) Ltd.
Manufacturer address line 1: P.O. Box 1459
Manufacturer address line 2: Mubarik Pura
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--GN
Importers product description: DENTAL SCISSORS(FOR EXPORT ONLY)
Refusal date: 10-MAR-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0063805-2/1/2/
Carrier: BRITISH AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3003080312
Manufacturer Name: Bontempi Chirurgische Instrumente OHG
Manufacturer address line 1: Bodenseestr. 1
Manufacturer address line 2:
Manufacturer City: Tuttlingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--GN
Importers product description: 861539204042 SCISSORS
Refusal date: 27-MAR-2008
FDA_District: DET-DO
Entry/doc/line/sfx: 112-1950883-8/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3006706863
Manufacturer Name: Global Top Inc
Manufacturer address line 1: 613 Dreamworld B/D
Manufacturer address line 2:
Manufacturer City: Gyeonggido
Manufacturer Province/state:
Manufacturer Country: Korea, Republic Of (South)
Product code: 76E--IH
Importers product description: 957362434775 TOPCERAM
Refusal date: 25-MAR-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-1675296-7/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NO 510(K)
Manufacturer FEI: 3003080312
Manufacturer Name: Bontempi Chirurgische Instrumente OHG
Manufacturer address line 1: Bodenseestr. 1
Manufacturer address line 2:
Manufacturer City: Tuttlingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--KI
Importers product description: 861539204042 CARRIER
Refusal date: 27-MAR-2008
FDA_District: DET-DO
Entry/doc/line/sfx: 112-1950883-8/1/2/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3006661230
Manufacturer Name: Prais' Reliable Dental Supplies
Manufacturer address line 1: 310 Premier Building
Manufacturer address line 2:
Manufacturer City: Riga
Manufacturer Province/state:
Manufacturer Country: Latvia
Product code: 76E--MA
Importers product description: FUJI CAPSULES LC-CEMENT
Refusal date: 10-MAR-2008
FDA_District: BLT-DO
Entry/doc/line/sfx: DE8-0808872-3/3/1/
Carrier: KALITTA AIR, LLC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3003080312
Manufacturer Name: Bontempi Chirurgische Instrumente OHG
Manufacturer address line 1: Bodenseestr. 1
Manufacturer address line 2:
Manufacturer City: Tuttlingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MG
Importers product description: 861539204042 FORCEPS
Refusal date: 27-MAR-2008
FDA_District: DET-DO
Entry/doc/line/sfx: 112-1950883-8/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3003080312
Manufacturer Name: Bontempi Chirurgische Instrumente OHG
Manufacturer address line 1: Bodenseestr. 1
Manufacturer address line 2:
Manufacturer City: Tuttlingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MJ
Importers product description: 861539204042 RONT ELEVATOR
Refusal date: 27-MAR-2008
FDA_District: DET-DO
Entry/doc/line/sfx: 112-1950883-8/1/3/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3000239727
Manufacturer Name: Acumen Surgical (Pvt) Ltd.
Manufacturer address line 1: P.O. Box 1459
Manufacturer address line 2: Mubarik Pura
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--MK
Importers product description: DENTAL CURETTES(FOR EXPORT ONLY)
Refusal date: 10-MAR-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0063805-2/1/3/
Carrier: BRITISH AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 1000502030
Manufacturer Name: Qayum & Elahisons (Pvt) Ltd
Manufacturer address line 1: P. O. Box 14
Manufacturer address line 2:
Manufacturer City: Sialkot
Manufacturer Province/state:
Manufacturer Country: Pakistan
Product code: 76E--MS
Importers product description: DENTAL PERIODONTIC CURETTE
Refusal date: 19-MAR-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9094937-7/1/1/
Carrier: BRITISH AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): STAINSTEEL
Manufacturer FEI: 3002578688
Manufacturer Name: Takara Belmont Co Ltd
Manufacturer address line 1: 1 1 2 Chime
Manufacturer address line 2:
Manufacturer City: Osaka
Manufacturer Province/state:
Manufacturer Country: Japan
Product code: 76K--LC
Importers product description: HYDRAULIC DOCTOR STOOL FOR EXPORT ONLY REG#9611445
Refusal date: 10-MAR-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: DM9-8010094-3/1/1/
Carrier: MITSUI O S K LINES LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006691299
Manufacturer Name: Esro Ag
Manufacturer address line 1: Dorfstrasse 143
Manufacturer address line 2:
Manufacturer City: Kilchberg
Manufacturer Province/state:
Manufacturer Country: Switzerland
Product code: 76M--CF
Importers product description: BRUSH
Refusal date: 10-MAR-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: KL3-0084227-7/1/1/
Carrier: CARGOLUX AIRLINES INTERNATION
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED