Identity
- Trade Name
- Universal Ti Cylinder FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- CUATC486 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800023134926 FDA UDI
- 510(k) Number
- K210039 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
The Universal Ti Cylinder is a high-quality, prefabricated dental implant device designed to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). With its durable and adjustable design, it offers excellent stability and comfort for patients. This device is ideal for use in various clinical settings, including general dentistry and specialized clinics.
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
Cleared under the same submission
K210039 also covers:
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
- Angled Abutment — Cybermed Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Cybermed Inc.
Sources (1)
- FDA UDI 4e7d35bf-1d11-4756-bb60-b169b29cf19c 34 fields · synced Jul 22, 2026