Zirconia Polishing Kit Ca

FDA UDI

Class I (US FDA UDI)

by Shofu Dental Corp.

Identity

Trade Name: ZIRCONIA POLISHING KIT CA FDA UDI
Generic Name: Dental abrasive point, reusable FDA UDI
Device Name: Contains DIs: E23506580; E23506650; E23506700; E23506630; E23506680; E23506730; E23506610; E23506660; E23506710 FDA UDI
Model / Reference: 0333B FDA UDI
Description: Contains DIs: E23506580; E23506650; E23506700; E23506630; E23506680; E23506730; E23506610; E23506660; E23506710 FDA UDI

Identifiers

Catalog Number: 0333B FDA UDI
Primary DI / UDI-DI: E2350333B0 FDA UDI
FDA Product Code: EHL FDA UDI
GMDN Term: Dental abrasive point, reusable 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental abrasive point, reusable

Zirconia Polishing Kit Ca by Shofu Dental Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive point, reusable.

MALIBU SEPARATORS — AMERICAN TOOTH INDUSTRIES · Class I
HORICO — Hopf, Ringleb & Co. GmbH & Cie. · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class I
KOMET Abrasive Instruments — Gebr. Brasseler GmbH & Co. KG · Class I
EDENTA — EDENTA ETABLISSEMENT · Class I
EDENTA — EDENTA ETABLISSEMENT · Class I
Alpen — Coltene/Whaledent Inc. · Class I
Strauss Diamond — Diamond Strauss Instruments Inc · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Shofu Dental Corp.

Sources (1)

FDA UDI eba5511a-f701-4743-aa35-0518c286db31 36 fields · synced Jun 8, 2026