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Perfectemp®10 CR1218

by Den-Mat Holdings, LLC

Perfectemp®10 CR1218 is a Class II device made by Den-Mat Holdings, LLC, cleared under FDA 510(k) K122039 on 27 Dec 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI D813CR12180), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K122039

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD813CR12180 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122039 Date27 Dec 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122039 decided 27 Dec 2012 Active
  • FDA GUDID UDI-DI D813CR12180 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122039
  2. Listed FDA GUDID D813CR12180

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Perfectemp®10
Generic name
Dental composite resin
Model / Ref / Catalog
CR1218
Primary DI / UDI-DI
D813CR12180
510(k) Number
FDA product code
EBG
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

Cleared under the same submission (K122039)

and 8 more cleared under K122039

Other devices from Den-Mat Holdings, LLC

See all devices from Den-Mat Holdings, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)