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BAOT JC Semi-transparent Enamel Effect EE-1A

by BAOT Biological Technology Co., Ltd.

Ref 06973133310541Model Metal Ceramic, Zirconia Ceramic, and associated accessory (Formative Liquid)

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697313331CE01BG Basic UDI-DI 06973133310541UDI-DIDate17 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06973133310541 UDI-DI Date8 Jul 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Dental Ceramic EUDAMED
Baot GUDID
Generic Name
Dental appliance fabrication material, ceramic
Model / Reference
Metal Ceramic EUDAMED
Zirconia Ceramic EUDAMED
and associated accessory (Formative Liquid) EUDAMED
06973133310541 EUDAMED
JC Semi-transparent Enamel Effect EE-1A GUDID
Primary DI / UDI-DI
06973133310541
Basic UDI-DI
697313331CE01BG
510(k) Number
FDA Product Code
EIH
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Metal Ceramic, Zirconia Ceramic, and associated accessory (Formative Liquid)
06973133310541
GUDID
JC Semi-transparent Enamel Effect EE-1A
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Cleared under the same submission (K182350)

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Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No