RP Natural Profile Abutment 7.0mm x 1.0mm

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: RP Natural Profile Abutment 7.0mm x 1.0mm FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: The Natural Profile Abutment enables the clinician to restore cases that are periodontally and aesthetically demanding. This versatile system permits the development of an emergence profile which is in harmony with the soft tissue. Final margination can be prepared to accurately follow the gingival contours in order to achieve maximum aesthetics. Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants. FDA UDI
Model / Reference: 904248 FDA UDI
Description: The Natural Profile Abutment enables the clinician to restore cases that are periodontally and aesthetically demanding. This versatile system permits the development of an emergence profile which is in harmony with the soft tissue. Final margination can be prepared to accurately follow the gingival contours in order to achieve maximum aesthetics. Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549110689 FDA UDI
510(k) Number: K892124 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

RP Natural Profile Abutment 7.0mm x 1.0mm 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

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 67855d56-91b0-44c3-8955-da2bc0a753a2 36 fields · synced Jun 8, 2026