Identity
- Trade Name
- Dental Putty Syringe 2.0cc FDA UDI
- Generic Name
- Dental bone matrix implant, synthetic FDA UDI
- Device Name
- Synthetic bone void filler for dental applications FDA UDI
- Model / Reference
- ND1612 FDA UDI
- Description
- Synthetic bone void filler for dental applications FDA UDI
Identifiers
- Catalog Number
- ND1612 FDA UDI
- Primary DI / UDI-DI
- 00813909013343 FDA UDI
- 510(k) Number
- K100671 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Dental bone matrix implant, synthetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Dental bone matrix implant, synthetic
Dental Putty Syringe 2.0cc by NovaBone Products, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100671 also covers:
- Dental Putty - 6 x 0.5cc — NovaBone Products, LLC
- Dental Putty - 6 x 0.5cc — NovaBone Products, LLC
- Dental Putty 0.5cc — NovaBone Products, LLC
- Dental Putty 0.5cc — NovaBone Products, LLC
- Dental Putty 1.0cc — NovaBone Products, LLC
- Dental Putty 2 x 1.5cc — NovaBone Products, LLC
- Dental Putty Cartridge 2 x 0.5cc — NovaBone Products, LLC
- Dental Putty Cartridge 2 x 0.5cc — NovaBone Products, LLC
- Dental Putty Cartridge 2 x 1.0cc — NovaBone Products, LLC
- Dental Putty Cartridge 4 x 0.25cc — NovaBone Products, LLC
- Dental Putty Cartridge 4 x 0.5cc — NovaBone Products, LLC
- Dental Putty Cartridge 6 x 0.5cc — NovaBone Products, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NovaBone Products, LLC
Sources (1)
- FDA UDI b2bed852-3d6d-4606-8c5a-53f67280b4d9 37 fields · synced Jun 9, 2026