ERA® Std. Imp. Abutment Tool Kit

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: ERA® Std. Imp. Abutment Tool Kit FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Tool Kit Includes: ERA Torque Driver, ERA I/A ratchet, ERA Plastic Handles (2), ERA Core Cutter, ERA Seating tool. Includes all tools necessary to complete any standard Implant Abutment. FDA UDI
Model / Reference: 811908 FDA UDI
Description: Tool Kit Includes: ERA Torque Driver, ERA I/A ratchet, ERA Plastic Handles (2), ERA Core Cutter, ERA Seating tool. Includes all tools necessary to complete any standard Implant Abutment. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549116377 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

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

ERA® Std. Imp. Abutment Tool Kit 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 cef9dfc2-a00b-4ede-978f-58569d1a5239 34 fields · synced May 30, 2026