Identity
- Trade Name
- RegenaVate™ DBM Fill RT, 0.5cc FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Model / Reference
- ZR0105 FDA UDI
Identifiers
- Catalog Number
- 013005Z FDA UDI
- Primary DI / UDI-DI
- 00854095006740 FDA UDI
- 510(k) Number
- K080418 FDA UDI
- FDA Product Code
- NUN FDA UDI
- GMDN Term
- Bone matrix implant, human-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
RegenaVate™ DBM Fill RT, 0.5cc by Rti Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K080418 also covers:
- RegenaVate™ Formable DBM RT, 1cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM RT, 1cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM RT, 2cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM RT, 2cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2cc — Rti Surgical, Inc.
- RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2cc — Rti Surgical, Inc.
- Allo-3D-Plus — SALVIN DENTAL SPECIALTIES, LLC
- Allo-3D-Plus — SALVIN DENTAL SPECIALTIES, 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 |
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Manufacturer
- Manufacturer
- Rti Surgical, Inc.
Sources (1)
- FDA UDI f5dc6b5f-78f3-4917-bfbd-01b8100a5d14 36 fields · synced Jun 6, 2026