Zubler USA

FDA UDI

Class I (US FDA UDI)

by Opa Dental, Llc

Identity

Trade Name: Zubler USA FDA UDI
Generic Name: Dental abrasive disk, single-use FDA UDI
Device Name: Chairside rotary tool adjustment kit for crowns. Kit contains discs (LXZW), points (NCFW), and burs (HGDH) FDA UDI
Model / Reference: PKDZLZ FDA UDI
Description: Chairside rotary tool adjustment kit for crowns. Kit contains discs (LXZW), points (NCFW), and burs (HGDH) FDA UDI

Identifiers

Catalog Number: PKDZLZ FDA UDI
Primary DI / UDI-DI: D815PKDZLZ0 FDA UDI
FDA Product Code: EHJ FDA UDI
GMDN Term: Dental abrasive disk, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Dry Heat Sterilization FDA UDI

Category: Dental abrasive disk, single-use

Zubler USA by Opa Dental, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PRAXIS — TDV DENTAL LTDA · 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: Opa Dental, Llc

Sources (1)

FDA UDI 91ebd775-31db-4072-b276-a16f1616baa1 34 fields · synced May 30, 2026