Identity
- Trade Name
- Angled Abutment 15° 4.0mm Cuff FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Angled Abutment are available for cases where implants are not able to provide alignments leading to clinical parallelism. Available in 15 and 30 degree angulations, they offer the clinician a wide range of three-dimensional options. Their internal design allows them to be locked into any one of twelve rotational positions. The 15 degree Angled Abutments are designed for use with cemented prostheses, and the 30 degree Angled Abutments for cemented or screw retained prostheses. FDA UDI
- Model / Reference
- 904318 FDA UDI
- Description
- Angled Abutment are available for cases where implants are not able to provide alignments leading to clinical parallelism. Available in 15 and 30 degree angulations, they offer the clinician a wide range of three-dimensional options. Their internal design allows them to be locked into any one of twelve rotational positions. The 15 degree Angled Abutments are designed for use with cemented prostheses, and the 30 degree Angled Abutments for cemented or screw retained prostheses. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549110962 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
Angled Abutment 15° 4.0mm Cuff by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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 2c424803-563f-48ae-971e-d44a1758d10f 35 fields · synced May 30, 2026