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PremEco Line Prothetik Color System Refill: colour opal 8g

by Merz Dental GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD7091030010 UDI-DI Date17 Jul 2018ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PremEco Line Prothetik Color System
Generic Name
Dental appliance fabrication material, resin
Model / Ref / Catalog
Refill: colour opal 8g, 1030010
Primary DI / UDI-DI
D7091030010
510(k) Number
FDA Product Code
EBI
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class II
Regulation Number
872.3760
GUDID distribution status
In Commercial Distribution
Size
Weight — 8 Gram

Related devices

Category: Dental appliance fabrication material, resin

Cleared under the same submission (K130076)

Show all (12)

Other devices from Merz Dental GmbH

See all devices from Merz Dental GmbH →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No