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Premier Mirror Warmer

by Premier Dental Products Co.

510(k) K945395

Premier Mirror Warmer is a medical device (FDA Class I; FDA product code ETF, Unit, Examining/Treatment, Ent) made by Premier Dental Products Co., cleared under FDA 510(k) K945395 on 18 Jan 1995, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945395 Date18 Jan 1995ClearedStatusActive

Official records

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  • Withdrawn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
ETF
Device class
Class I
Regulation
21 CFR Part 874.5300
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code ETF (Unit, Examining/Treatment, Ent).

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