Identity
- Trade Name
- DENTAL ATTACHMENTS FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- KIT containing - single spheres: SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis. - pink retentive caps: DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention. - stainless steel housings: DISPOSABLE device used to contain the retentive cap inside the removable prosthesis. - plastic positioners: SINGLE USE plastic device. Centering ring for castable housings. FDA UDI
- Model / Reference
- OT CAP STANDARD size FDA UDI
- Description
- KIT containing - single spheres: SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis. - pink retentive caps: DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention. - stainless steel housings: DISPOSABLE device used to contain the retentive cap inside the removable prosthesis. - plastic positioners: SINGLE USE plastic device. Centering ring for castable housings. FDA UDI
Identifiers
- Catalog Number
- 092CAN FDA UDI
- Primary DI / UDI-DI
- 08059224001050 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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 implant suprastructure, permanent, preformed
Dental Attachments by Rhein 83 Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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 |
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Manufacturer
- Manufacturer
- Rhein 83 Srl
Sources (1)
- FDA UDI 03bf3b9e-2b73-4a46-8021-f421f45c2325 34 fields · synced May 30, 2026