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VIVID Tone 66

by Mdc Dental 2 variants

VIVID Tone 66 is a Class II device made by Mdc Dental, cleared under FDA 510(k) K991577 on 22 Sep 1999 and listed in FDA GUDID since 20 Jul 2026 (UDI-DI 07506338322560), 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) K991577

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 Number07506338322560 UDI-DI Date20 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK991577 Date22 Sep 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K991577 decided 22 Sep 1999 Active
  • FDA GUDID UDI-DI 07506338322560 listed 20 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K991577
  2. Listed FDA GUDID 07506338322560

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vivid
Generic name
Dental acrylic resin
Model / reference
Tone 66
Primary DI / UDI-DI
07506338322560
510(k) Number
FDA product code
EBG
GMDN term
Dental acrylic resin
Device class
Class II
Regulation number
872.3770
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EBG (Crown And Bridge, Temporary, Resin).

Other devices from Mdc Dental

See all devices from Mdc Dental →

Properties

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