Helmut Zepf

FDA UDI

Class I (US FDA UDI)

by Helmut Zepf Medizintechnik GmbH

Identity

Trade Name: HELMUT ZEPF FDA UDI
Generic Name: Dental matrix band, reusable FDA UDI
Device Name: FINISHING STRIP, PLASTIC, 4X183, ONE SIDE COATED, LEFT MICRO FINE, RIGHT MICRO MIDDLE-FINE FDA UDI
Model / Reference: 19.066.04 FDA UDI
Description: FINISHING STRIP, PLASTIC, 4X183, ONE SIDE COATED, LEFT MICRO FINE, RIGHT MICRO MIDDLE-FINE FDA UDI

Identifiers

Catalog Number: 19.066.04 FDA UDI
Primary DI / UDI-DI: EZPF19066040 FDA UDI
FDA Product Code: JEP FDA UDI
GMDN Term: Dental matrix band, reusable 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental matrix band, reusable

Helmut Zepf by Helmut Zepf Medizintechnik GmbH — 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: Helmut Zepf Medizintechnik GmbH

Sources (1)

FDA UDI a2924e7e-7a97-4c12-af03-c5ded9a632ac 35 fields · synced Jun 7, 2026