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DENTOCORE BODY Automix A3

by Itena Clinical

DENTOCORE BODY Automix A3 (ECHDCBODY) is a Class II device made by Itena Clinical, cleared under FDA 510(k) K121769 on 5 Mar 2013 and listed in FDA GUDID since 31 Oct 2017 (UDI-DI 03760260222082), active as of 23 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 23 Oct 2026

Documents

510(k) K121769

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760260222082 UDI-DI Date31 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK121769 Date5 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121769 decided 5 Mar 2013 Active
  • FDA GUDID UDI-DI 03760260222082 listed 31 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121769
  2. Listed FDA GUDID 03760260222082

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dentocore Body
Generic name
Dental composite resin
Model / Ref / Catalog
Automix A3, ECHDCBODY
Primary DI / UDI-DI
03760260222082
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

Cleared under the same submission (K121769)

Similar devices in this category

Other devices filed under Dental composite resin.

Other devices from Itena Clinical

See all devices from Itena Clinical →

Properties

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