Identity
- Trade Name
- ORA Retaining Ring FDA UDI
- Generic Name
- Resilient dental precision attachment FDA UDI
- Device Name
- The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture. . FDA UDI
- Model / Reference
- 904002 FDA UDI
- Description
- The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture. . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549110139 FDA UDI
- 510(k) Number
- K133791 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Resilient dental precision attachment 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Resilient dental precision attachment
ORA Retaining Ring by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Resilient dental precision attachment.
- NOBIL METAL SPA — NOBIL METAL SPA · Class I
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC. · Class I
- Preat — PREAT Corporation · Class I
- RevoCone Cap yellow, — bredent GmbH & Co. KG · Class I
- Preat — PREAT Corporation · Class I
- NOBIL METAL SPA — NOBIL METAL SPA · Class I
- Preat — PREAT Corporation · Class I
- Preci-Clix — PREAT Corporation · Class I
Cleared under the same submission
K133791 also covers:
- ORA Implant Abutment 1.0mm Cuff (AE) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (AJ) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (AK) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (AN) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (AP) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (AY) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (B) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (BD) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (BE) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (BF) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (BK) — Sterngold Dental LLC
- ORA Implant Abutment 1.0mm Cuff (C) — Sterngold Dental 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI cd7a2080-ad58-4503-b0d7-1c477f64d220 35 fields · synced May 30, 2026