Identity
- Trade Name
- GUIDED SLEEVE FDA UDI
- Generic Name
- Dental implantation drilling template guide-sleeve FDA UDI
- Device Name
- 4.0MM GUIDED SURGERY SLEEVE FDA UDI
- Model / Reference
- 4.0MM GUIDED SURGERY SLEEVE FDA UDI
- Description
- 4.0MM GUIDED SURGERY SLEEVE FDA UDI
Identifiers
- Catalog Number
- 4.0 GSS FDA UDI
- Primary DI / UDI-DI
- D78540GSS0 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implantation drilling template guide-sleeve FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implantation drilling template guide-sleeve
Guided Sleeve by Oco Biomedical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implantation drilling template guide-sleeve.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Inclusive® — PRISMATIK DENTALCRAFT, INC. · Class I
- SQ Mini Guide Sleeve — DENTIS CO. , LTD · Class I
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Implant-One — Implant Logistics, Inc. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- 3DDX Sleeve 260-160-4L — 3D DIAGNOSTIX, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oco Biomedical
Sources (1)
- FDA UDI 7188c5ad-3e48-4195-a7a2-e9b51d7893fb 34 fields · synced Jun 8, 2026