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Transcend

by Ultradent Product, Inc.

510(k) K201795

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK201795 Date28 Sep 2020ClearedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3068-2024 FDA Class II initiated 2 Aug 2024
    • Ongoing Z-3067-2024 FDA Class II initiated 2 Aug 2024

    Due to a manufacturing issue, red particulates present in the expressed composite.

Timeline

3 dated events

  1. Cleared FDA 510(k) K201795
  2. Recall initiated FDA recalls Z-3068-2024
  3. Recall initiated FDA recalls Z-3067-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EBF
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Transcend is a dental composite device designed for use in restorative dentistry. It utilizes Ultradent's Resin Particle Match™ technology to balance refractive indices between resin and filler particles, optimizing translucency and opacity to blend with surrounding dentition using a single shade.

The device is supplied as a composite material for dental restoration and is intended for use by dental professionals in clinical settings. It is cleared under FDA 510(k) with K-number K201795 and product code EBF, and is classified under the Dental advisory committee. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorizations is provided in the data.

Devices cleared under K201795

21 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K201795
UDI-DISize and differences
Composite Wetting Resin 3059
ULTRADENT PRODUCTS, INC.
3059 / 305900883205104205
Single use: no
On the market
Transcend 4726-
ULTRADENT PRODUCTS, INC.
4726- / 4726-00883205028259
Single use: no
On the market
Transcend 4727-
ULTRADENT PRODUCTS, INC.
4727- / 4727-00883205028099
Single use: no
On the market
Transcend 4728-
ULTRADENT PRODUCTS, INC.
4728- / 4728-00883205028105
Single use: no
On the market
Transcend 4729-
ULTRADENT PRODUCTS, INC.
4729- / 4729-00883205028112
Single use: no
On the market
Transcend 4730-
ULTRADENT PRODUCTS, INC.
4730- / 4730-00883205028129
Single use: no
On the market
Transcend 4731-
ULTRADENT PRODUCTS, INC.
4731- / 4731-00883205028136
Single use: no
On the market
Transcend 4732-
ULTRADENT PRODUCTS, INC.
4732- / 4732-00883205028143
Single use: no
On the market
Transcend 4733-
ULTRADENT PRODUCTS, INC.
4733- / 4733-00883205028150
Single use: no
On the market
Transcend 4734-
ULTRADENT PRODUCTS, INC.
4734- / 4734-00883205028167
Single use: no
On the market
Transcend 4744-
ULTRADENT PRODUCTS, INC.
4744- / 4744-00883205028273
Single use: yes
On the market
Transcend 4745-
ULTRADENT PRODUCTS, INC.
4745- / 4745-00883205028280
Single use: yes
On the market
Transcend 4746-
ULTRADENT PRODUCTS, INC.
4746- / 4746-00883205028297
Single use: yes
On the market
Transcend 4747-
ULTRADENT PRODUCTS, INC.
4747- / 4747-00883205028303
Single use: yes
On the market
Transcend 4748-
ULTRADENT PRODUCTS, INC.
4748- / 4748-00883205028310
Single use: yes
On the market
Transcend 4749-
ULTRADENT PRODUCTS, INC.
4749- / 4749-00883205028327
Single use: yes
On the market
Transcend 4757-
ULTRADENT PRODUCTS, INC.
4757- / 4757-00883205028334
Single use: yes
On the market
Transcend 4814-
ULTRADENT PRODUCTS, INC.
4814- / 4814-00883205028433
Single use: yes
On the market
Transcend 4817-
ULTRADENT PRODUCTS, INC.
4817- / 4817-00883205033680
Single use: yes
On the market
Transcend S4726-
ULTRADENT PRODUCTS, INC.
S4726- / S4726-00883205023919
Single use: no
On the market
Transcend S4814-
ULTRADENT PRODUCTS, INC.
S4814- / S4814-00883205023902
Single use: yes
On the market

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