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Sterngold Implant System Guided Surgery Kit (no tools)

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
Sterngold Implant System Guided Surgery Kit (no tools) FDA UDI
Generic Name
Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI
Device Name
Surgical kits are well-designed for easy and simple access to the surgical instruments for bone preparation and implant placement. The design of the containers is efficient, allowing placement of all needed instruments into grommets for easy access. This kit contains no instruments. FDA UDI
Model / Reference
905881 FDA UDI
Description
Surgical kits are well-designed for easy and simple access to the surgical instruments for bone preparation and implant placement. The design of the containers is efficient, allowing placement of all needed instruments into grommets for easy access. This kit contains no instruments. FDA UDI

Identifiers

Primary DI / UDI-DI
00841549119088 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental/maxillofacial surgical procedure kit, medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

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

Category: Dental/maxillofacial surgical procedure kit, medicated, reusable

Sterngold Implant System Guided Surgery Kit (no tools) by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental/maxillofacial surgical procedure kit, medicated, reusable.

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 08ff3646-2882-489f-969f-30f1b3d54456 34 fields · synced Jun 6, 2026