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TRU NP Healing Abutment 5mm, Ti

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
TRU NP Healing Abutment 5mm, Ti FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase. It is made out of 6AL-4V ELI Titanium Alloy, ASTM F136-12a. Device is supplied as a narrow platform with a 5mm cuff. FDA UDI
Model / Reference
901388 FDA UDI
Description
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase. It is made out of 6AL-4V ELI Titanium Alloy, ASTM F136-12a. Device is supplied as a narrow platform with a 5mm cuff. FDA UDI

Identifiers

Primary DI / UDI-DI
00841549107689 FDA UDI
510(k) Number
K150968 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

TRU NP Healing Abutment 5mm, Ti by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K150968 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 134fa369-6cf5-44a0-9c7d-85925715cb2e 36 fields · synced May 30, 2026