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Angled Abutment 15° 2.0mm Cuff

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
Angled Abutment 15° 2.0mm 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
904319 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
00841549110979 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
Not 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Angled Abutment 15° 2.0mm Cuff by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K892124 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sterngold Dental LLC

Sources (1)

  • FDA UDI a0cf55d9-f5fb-4acf-8c56-cb88725c95a2 36 fields · synced May 30, 2026