Skip to content

Vila Pc

by Health-Dent Intl., Inc.

510(k) K951380

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951380 Date27 Apr 1995ClearedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DYH
Device Class
Class II
Regulation
21 CFR Part 872.3750
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Health-Dent Intl., Inc.

  • Dent-Temp Acrylic

    Class II

  • Hema-Benz

    Class II

  • Algi-Band

    Class II

  • Vila

    Class II

  • Giroc

    Class II

  • Hema-Glu

    Class II

See all devices from Health-Dent Intl., Inc. →