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MiYO Esthetic System

by Jensen Industries, Inc. 5 variants

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 Number00817340026023 UDI-DI Date12 Feb 2026ListedStatusListed 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  • Withdrawn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

Generic Name
Dental porcelain/ceramic restoration kit
Model / Ref / Catalog
MiYO Hi Fusing Gingival Structure Frost Paste 4g, 0962
Primary DI / UDI-DI
00817340026023
510(k) Number
FDA Product Code
EIH
GMDN Term
Dental porcelain/ceramic restoration kit
Device Class
Class II
Regulation Number
872.6660
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K111743)

Show all (12)

Other devices from Jensen Industries, Inc.

See all devices from Jensen Industries, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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