Ratchet Wrench

FDA UDI

Class I (US FDA UDI)

by POINTIMPLANT Co., Ltd.

Identity

Trade Name: Ratchet Wrench FDA UDI
Generic Name: Dental torque wrench FDA UDI
Model / Reference: RWS FDA UDI

Identifiers

Primary DI / UDI-DI: 08800011265779 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

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

MRI Safety

MR Conditional FDA UDI

Category: Dental torque wrench

Ratchet Wrench by POINTIMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental torque wrench.

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Restore — Keystone Dental Inc. · Class I
4-Part Telescoping Herbst Replacement Parts — SPECIALTY APPLIANCES, LLC · Class I
RS 2.45 Hex Handpiece Adapter FLX - Short — ADIN DENTAL IMPLANT SYSTEMS LTD · Class I
Azure — TERRATS MEDICAL SL. · Class I
Graduated Torque Wrench — Sterngold Dental LLC · Class I
SURGICAL TORQUE RATCHET — S.I.N. - Sistema DE Implante Nacional S.A. · Class I

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: POINTIMPLANT Co., Ltd.

Sources (1)

FDA UDI 002d7d00-e24a-44ae-beef-9eff1f35d07e 32 fields · synced Jun 8, 2026