Torque Wrench Adjustable (15-60Ncm)

FDA UDI

Class I (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: Torque Wrench Adjustable (15-60Ncm) FDA UDI
Generic Name: Dental torque wrench FDA UDI
Device Name: Adjustable Torque wrench - take 4mm square head drivers/adapters - can be adjusted between 15-60Ncm FDA UDI
Model / Reference: Adjustable Torque Wrench FDA UDI
Description: Adjustable Torque wrench - take 4mm square head drivers/adapters - can be adjusted between 15-60Ncm FDA UDI

Identifiers

Catalog Number: Torque Wrench Adjustable FDA UDI
Primary DI / UDI-DI: 00083208230448 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Dental torque wrench FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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: Dental torque wrench

Torque Wrench Adjustable (15-60Ncm) by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Suncoast Dental, Inc.

Sources (1)

FDA UDI 0d69f98c-925a-417d-a248-ea093c37062d 36 fields · synced Jun 8, 2026