Dp-Repair

FDA UDI

Class II (US FDA UDI)

by Denplus Inc

Identity

Trade Name: DP-REPAIR FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: DP-REPAIR-F, CLR, 11.3 kg FDA UDI
Model / Reference: 1071300 FDA UDI
Description: DP-REPAIR-F, CLR, 11.3 kg FDA UDI

Identifiers

Catalog Number: 1071300 FDA UDI
Primary DI / UDI-DI: D8451071300 FDA UDI
510(k) Number: K991996 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Dental appliance fabrication material, resin

Dp-Repair by Denplus Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental appliance fabrication material, resin.

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HI-I® — FRICKE INTERNATIONAL, INC. · Class II
FREEPRINT crown A1 500g — DETAX GmbH · Class II

Cleared under the same submission

K991996 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Denplus Inc

Sources (1)

FDA UDI 90323c22-a6f6-483f-80dc-4e2e7e7f6735 35 fields · synced May 30, 2026