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Luxisse+ 0

by Heany Industries, Inc. 68 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 Number00817724021767 UDI-DI Date15 Mar 2017ListedStatusListed 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  • Withdrawn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
Luxisse+
Generic Name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
0, MDCY0669ZSCB2
Primary DI / UDI-DI
00817724021767
510(k) Number
FDA Product Code
EIH
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class II
Regulation Number
872.6660
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 17 Millimeter

Related devices

Category: Dental appliance fabrication material, ceramic

Cleared under the same submission (K150056)

Show all (12)

Other devices from Heany Industries, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: 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
  • Manufacturing Date: No