Identity
- Trade Name
- osseolink Implant FDA UDI
- Generic Name
- Dental drilling system attachment FDA UDI
- Device Name
- Step Drill ø 3.5 mm FDA UDI
- Model / Reference
- STD35 FDA UDI
- Description
- Step Drill ø 3.5 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816273020573 FDA UDI
- 510(k) Number
- K091878 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental drilling system attachment FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Radiation Sterilization FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Width — 3.5 Millimeter FDA UDI
Category: Dental drilling system attachment
osseolink Implant by Osseolink Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental drilling system attachment.
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- DELFIN2 — Intra-Lock International · Class I
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Cleared under the same submission
K091878 also covers:
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA 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
- Osseolink Usa Llc
Sources (1)
- FDA UDI a297360b-07a8-4ae8-b3bd-38010beaf323 37 fields · synced Jun 8, 2026