Identity
- Trade Name
- ZERO-G Bio Implant Cement FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- ZERO-G™ is a dual-cure implant cement and is recommended for intermediate to long-term cementation of implant-retained restorations. Retrievable, easy to see, simple removal of excess cement. FDA UDI
- Model / Reference
- 7 gm Syringe - 1pc FDA UDI
- Description
- ZERO-G™ is a dual-cure implant cement and is recommended for intermediate to long-term cementation of implant-retained restorations. Retrievable, easy to see, simple removal of excess cement. FDA UDI
Identifiers
- Catalog Number
- 46-1005 FDA UDI
- Primary DI / UDI-DI
- D8374610050 FDA UDI
- 510(k) Number
- K141503 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 7 Gram FDA UDI
Category: Dental composite resin
ZERO-G Bio Implant Cement by Taub Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Llis — Dentscare Ltda · Class II
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K141503 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Taub Products
Sources (1)
- FDA UDI 920f2094-284c-41ea-9a09-042988cdb85a 38 fields · synced May 30, 2026