Skip to content

Health-Tec VPS Impression Material 290-00010

by Dental Health Products Inc

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD77329000101 UDI-DI Date24 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Health-Tec VPS Impression Material
Generic Name
Silicone dental impression material
Model / Ref / Catalog
290-00010
Primary DI / UDI-DI
D77329000101
510(k) Number
FDA Product Code
ELW
GMDN Term
Silicone dental impression material
Device Class
Class II
Regulation Number
872.3660
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K801380)

Show all (12)

Other devices from Dental Health Products Inc

See all devices from Dental Health Products Inc →

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