Restore

FDA UDI

Class I (US FDA UDI)

by Keystone Dental Inc.

Identity

Trade Name: Restore FDA UDI
Generic Name: Dental torque wrench FDA UDI
Device Name: Adapter FDA UDI
Model / Reference: L1806-03K FDA UDI
Description: Adapter FDA UDI

Identifiers

Primary DI / UDI-DI: D768L180603K0 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental torque wrench 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

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

FDA UDI

Category: Dental torque wrench

Restore by Keystone Dental Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Azure — TERRATS MEDICAL SL. · Class I
Graduated Torque Wrench — Sterngold Dental LLC · Class I
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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: Keystone Dental Inc.

Sources (1)

FDA UDI acb69f95-4838-4ebb-be95-84c97f51dd6a 34 fields · synced May 30, 2026