Identity
- Trade Name
- RP Gold Prosthetic Cylinder 3.0mm height FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Gold Cylinder (64% Gold, 22% Palladium) provides precision fit to abutment. Melting Range 1320°C-1370°C (2400°F-2500°F). Used for Fabrication of Final Restoration. Plastic Cylinders are fabricated to assure clean burnout. FDA UDI
- Model / Reference
- 904137 FDA UDI
- Description
- Gold Cylinder (64% Gold, 22% Palladium) provides precision fit to abutment. Melting Range 1320°C-1370°C (2400°F-2500°F). Used for Fabrication of Final Restoration. Plastic Cylinders are fabricated to assure clean burnout. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549110443 FDA UDI
- 510(k) Number
- K892124 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
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
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: Dental implant suprastructure, permanent, preformed
RP Gold Prosthetic Cylinder 3.0mm height by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 7f9b1447-566b-498c-9249-61a660c89beb 35 fields · synced May 30, 2026