Transcend

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 4728Ref 4748Ref 4731Ref 4727Ref 4726Ref 4814Ref 4744Ref 4733Ref 4746Ref 4757

by Ultradent Products, Inc.

Identity

Trade Name: Transcend EUDAMEDFDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Transcend EUDAMED
Transcend Syringe Refill, EN FDA UDI
Transcend Syringe Refill, A2D FDA UDI
Transcend Singles A1D Refill 10pk FDA UDI
Transcend Singles Refill 10pk, EN FDA UDI
Transcend Syringe Refill, UB FDA UDI
Transcend Syringe A1D Refill FDA UDI
Transcend Singles Intro Kit FDA UDI
Transcend Syringe Intro Kit FDA UDI
Transcend Singles Refill 10pk, UB FDA UDI
Transcend Singles Refill 10pk, A3D FDA UDI
Model / Reference: 4728 EUDAMED
4748 EUDAMED
4731 EUDAMED
4727 EUDAMED
4726 EUDAMED
4814 EUDAMED
4744 EUDAMED
4733 EUDAMED
4746 EUDAMED
4757 EUDAMED
4731- FDA UDI
4728- FDA UDI
4744- FDA UDI
4748- FDA UDI
4733- FDA UDI
4727- FDA UDI
4814- FDA UDI
4726- FDA UDI
4757- FDA UDI
4746- FDA UDI
Description: Transcend Syringe Refill, EN FDA UDI
Transcend Syringe Refill, A2D FDA UDI
Transcend Singles A1D Refill 10pk FDA UDI
Transcend Singles Refill 10pk, EN FDA UDI
Transcend Syringe Refill, UB FDA UDI
Transcend Syringe A1D Refill FDA UDI
Transcend Singles Intro Kit FDA UDI
Transcend Syringe Intro Kit FDA UDI
Transcend Singles Refill 10pk, UB FDA UDI
Transcend Singles Refill 10pk, A3D FDA UDI

Identifiers

Catalog Number: 4731- FDA UDI
4728- FDA UDI
4744- FDA UDI
4748- FDA UDI
4733- FDA UDI
4727- FDA UDI
4814- FDA UDI
4726- FDA UDI
4757- FDA UDI
4746- FDA UDI
Primary DI / UDI-DI: 00883205028136 EUDAMEDFDA UDI
00883205028105 EUDAMEDFDA UDI
00883205028273 EUDAMEDFDA UDI
00883205028310 EUDAMEDFDA UDI
00883205028150 EUDAMEDFDA UDI
00883205028099 EUDAMEDFDA UDI
00883205028433 EUDAMEDFDA UDI
00883205028259 EUDAMEDFDA UDI
00883205028334 EUDAMEDFDA UDI
00883205028297 EUDAMEDFDA UDI
Basic UDI-DI: 0883205-TF271TransHJ EUDAMED
510(k) Number: K201795 FDA UDI
FDA Product Code: EBF FDA UDI
EMDN Code: Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDIFDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDIFDA 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

Transcend by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin.

Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
SimpliShade — KERR CORPORATION · Class II
Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ultradent Products, Inc.

Sources (20)

FDA UDI 41a1f22e-9251-4f14-9a7a-b4a129731955 37 fields · synced Sep 17, 2026
FDA UDI 22a5b006-5471-4aa7-aa3f-44dcb687abb4 37 fields · synced May 29, 2026
FDA UDI 895bfb76-a5af-4bd2-bbfe-27f6df5d4c58 37 fields · synced May 29, 2026
FDA UDI a4ebe9ed-f9eb-4cbf-8f9e-2980f6e4386a 37 fields · synced May 29, 2026
FDA UDI 6e1adf80-cc08-400b-932f-6e9f177a97ea 37 fields · synced May 30, 2026
FDA UDI eb6517ec-c6dc-412d-b482-7e6931666705 37 fields · synced May 30, 2026
FDA UDI 3965fa8f-f0a6-4e7c-9634-f6b9bb930ee3 37 fields · synced May 30, 2026
FDA UDI 7fcec1c9-e3f8-40c3-a0db-aa7806a42998 37 fields · synced May 30, 2026
FDA UDI 4379a9f1-4dd5-463a-918d-aa6135a5ce45 37 fields · synced May 30, 2026
FDA UDI 01486729-2198-4430-b09a-1d8e180b93c8 37 fields · synced May 30, 2026
EUDAMED a4807a12-d288-4b49-87a1-c2d7c6850734 61 fields · synced Jul 9, 2026
EUDAMED 1b672352-b211-4cd0-8c0d-9b3669a7fb10 61 fields · synced Jul 9, 2026
EUDAMED 96be01fa-62f4-4d40-bdc5-730d83151d54 61 fields · synced Jul 10, 2026
EUDAMED b13b5e94-6f4b-4a68-b5ac-74a9517cf778 61 fields · synced Jul 15, 2026
EUDAMED 7dd1c426-bfab-4af5-b9fe-6f10775c49b1 61 fields · synced Jul 16, 2026
EUDAMED dc953238-7971-429d-b7fa-411087d07740 61 fields · synced Jul 20, 2026
EUDAMED 1f854c51-8a49-4af0-8dd8-d23463203009 61 fields · synced Jul 20, 2026
EUDAMED 82458f60-f1d3-45e9-84ff-417be3983187 61 fields · synced Jul 24, 2026
EUDAMED a8a5e2dc-c39a-4ad1-911b-9dddcf08c32b 61 fields · synced Aug 4, 2026
EUDAMED febe9b1d-223b-4554-b204-13e089408177 61 fields · synced Sep 17, 2026