Impact-Plus

FDA UDI

Class II (US FDA UDI)

by Denplus Inc

Identity

Trade Name: IMPACT-PLUS FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: iMPACT-PLUS, SPI. FDA UDI
Model / Reference: 1011204 FDA UDI
Description: iMPACT-PLUS, SPI. FDA UDI

Identifiers

Catalog Number: 1011204 FDA UDI
Primary DI / UDI-DI: D8451011204 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

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

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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 345f23d1-09c2-43ef-867d-792b87359cbf 35 fields · synced May 30, 2026