Prima

FDA UDI

Class I (US FDA UDI)

by Keystone Dental Inc.

Identity

Trade Name: Prima FDA UDI
Generic Name: Dental torque wrench FDA UDI
Device Name: Driver O-Ring FDA UDI
Model / Reference: ISS1111K FDA UDI
Description: Driver O-Ring FDA UDI

Identifiers

Primary DI / UDI-DI: D768ISS1111K0 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

Prima by Keystone Dental Inc. — 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: Keystone Dental Inc.

Sources (1)

FDA UDI 91858196-bf8a-4857-ac89-d846d3b7b1fa 34 fields · synced Jun 8, 2026