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VisCalor 6109

by VOCO GmbH

VisCalor 6109 is a Class II device made by VOCO GmbH, cleared under FDA 510(k) K201307 on 8 Jul 2020 and listed in FDA GUDID since 22 Jul 2020 (UDI-DI E22161091), 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) K201307

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 NumberE22161091 UDI-DI Date22 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK201307 Date8 Jul 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201307 decided 8 Jul 2020 Active
  • FDA GUDID UDI-DI E22161091 listed 22 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201307
  2. Listed FDA GUDID E22161091

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VisCalor
Generic name
Dental composite resin
Model / Ref / Catalog
6109
Primary DI / UDI-DI
E22161091
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 (K201307)

and 8 more cleared under K201307

Similar devices in this category

Other devices filed under Dental composite resin.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)