FDA.reportPublic FDA data

Fixture Lab Analog

Primary DI
00810112921571
Brand
Fixture Lab Analog
Company
Inosys, Inc.
Model
PBFAN M35H
Device description
Biotem AR FIXTURE LAB ANALOG 3.4Ø(aqua)
Published
2022-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112921571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112921571008101129215718101129215710810112921571

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
101803383
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112921625Pick-Up Impression Coping(Non-Hex)PBIP M45SN2024-02-13
00810112921632Pick-Up Impression Coping(Non-Hex)PBIP M45LN2024-02-13
00810112921649Pick-Up Impression Coping(Non-Hex)PBIP R45SN2024-02-13
00810112921656Pick-Up Impression Coping(Non-Hex)PBIP R45LN2024-02-13
00810112921588Fixture Lab AnalogPBFAN R37H2022-06-17
00810112921595Fixture Lab AnalogPBFAN R40H2022-06-17
00810112921120PRIMUS Implant SystemPBCA R4555N2022-06-15
00810112921137PRIMUS Implant SystemPBCA R4565N2022-06-15
00810112921144PRIMUS Implant SystemPBCA R4517N2022-06-15
00810112921151PRIMUS Implant SystemPBCA R4527N2022-06-15
00810112921168PRIMUS Implant SystemPBCA R4537N2022-06-15
00810112921175PRIMUS Implant SystemPBCA R4547N2022-06-15
00810112921182PRIMUS Implant SystemPBCA R5514N2022-06-15
00810112921199PRIMUS Implant SystemPBCA R5524N2022-06-15
00810112921205PRIMUS Implant SystemPBCA R5534N2022-06-15
00810112921212PRIMUS Implant SystemPBCA R5544N2022-06-15
00810112921229PRIMUS Implant SystemPBCA R5515N2022-06-15
00810112921236PRIMUS Implant SystemPBCA R5525N2022-06-15
00810112921243PRIMUS Implant SystemPBCA R5535N2022-06-15
00810112921250PRIMUS Implant SystemPBCA R5545N2022-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03