Bite Occlusion Rims - Wax

FDA UDI

Class I (US FDA UDI)

by Denplus Inc

Identity

Trade Name: Bite Occlusion Rims - Wax FDA UDI
Generic Name: Bite registration rim wax FDA UDI
Device Name: Bite Occlusion Rims - Wax, Pink, 100 units FDA UDI
Model / Reference: 3003101 FDA UDI
Description: Bite Occlusion Rims - Wax, Pink, 100 units FDA UDI

Identifiers

Catalog Number: 3003101 FDA UDI
Primary DI / UDI-DI: D8453003101 FDA UDI
FDA Product Code: EGD FDA UDI
GMDN Term: Bite registration rim wax FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6890 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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Bite registration rim wax

Bite Occlusion Rims - Wax by Denplus Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bite registration rim wax.

StoneBite® — Dreve Dentamid GmbH · Class II
Bite Rim Sticks — YAMAHACHI DENTAL MFG., CO. · Class I
StoneBite® Introduction Package — Dreve Dentamid GmbH · Class II
Take 1 Advanced — KERR CORPORATION · Class II
ROGSON WAX, MDC Dental — MDC DENTAL · Class I
Hexa — Hexa Dental · Class II
ALMORE BITE REGISTRATION TABS — Hager Worldwide, Inc. · Class I
Nobilium — CMP INDUSTRIES LLC · 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: Denplus Inc

Sources (1)

FDA UDI 0e603d81-0f20-4790-bd43-76f63c1c92a6 34 fields · synced May 31, 2026