ORA Implant Abutment .096 Hex Driver

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: ORA Implant Abutment .096 Hex Driver FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Abutments are tightened to 20 Ncm, using a .096” hex tool which engages the hex at the base of the ball. Manufactured from stainless steel that allows for the instrument to be clean in steam autoclaves. FDA UDI
Model / Reference: 904066 FDA UDI
Description: Abutments are tightened to 20 Ncm, using a .096” hex tool which engages the hex at the base of the ball. Manufactured from stainless steel that allows for the instrument to be clean in steam autoclaves. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549116629 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical screwdriver, 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

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

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

Category: Surgical screwdriver, reusable

ORA Implant Abutment .096 Hex Driver by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Sterngold Dental LLC

Sources (1)

FDA UDI f29b9eff-bcd0-4667-9d3a-735b8c9f768b 34 fields · synced Jun 8, 2026