New Customer Welcome

FDA UDI

Class II (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name: New Customer Welcome FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: New Dentist Welcome Kit FDA UDI
Model / Reference: S2931- FDA UDI
Description: New Dentist Welcome Kit FDA UDI

Identifiers

Catalog Number: S2931- FDA UDI
Primary DI / UDI-DI: 00883205019738 FDA UDI
510(k) Number: K112517 FDA UDI
FDA Product Code: EBC FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3765 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

Yes

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

Category: Dental composite resin

New Customer Welcome by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
CLEARFIL MAJESTY ES Flow Universal　Low (U) — Kuraray Noritake Dental Inc. Kurashiki · Class IIa

Cleared under the same submission

K112517 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: Ultradent Products, Inc.

Sources (1)

FDA UDI 8103dbec-6d71-4eaf-bdba-11cbffb6468e 37 fields · synced Jun 8, 2026