DenBite

FDA UDI

Class I (US FDA UDI)

by DuPhaMed B.V.

Identity

Trade Name: DenBite FDA UDI
Generic Name: Dental x-ray film holder, reusable FDA UDI
Device Name: Phosphor Plate Holder Introduction Pack, content: 2x bitewing - UDI 08717228440243 2x posterior/periapical L - UDI 08717228440229 2x posterior/periapical R - UDI 08717228440236 50 x clip - UDI 08717228441790 1x positioning ring - UDI 8717228441028 FDA UDI
Model / Reference: DBP3012 FDA UDI
Description: Phosphor Plate Holder Introduction Pack, content: 2x bitewing - UDI 08717228440243 2x posterior/periapical L - UDI 08717228440229 2x posterior/periapical R - UDI 08717228440236 50 x clip - UDI 08717228441790 1x positioning ring - UDI 8717228441028 FDA UDI

Identifiers

Primary DI / UDI-DI: 08717228440151 FDA UDI
FDA Product Code: EGZ FDA UDI
GMDN Term: Dental x-ray film holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.1905 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

Yes

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 x-ray film holder, reusable

DenBite by DuPhaMed B.V. — 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: DuPhaMed B.V.

Sources (1)

FDA UDI 7c120f1d-dbca-4271-80c9-c3a2b96f9033 33 fields · synced May 30, 2026