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Premier Inlay Placer

by Premier Dental Products Co.

510(k) K781034

Premier Inlay Placer is a medical device (FDA Class I; FDA product code EKI, Carrier, Amalgam, Operative) made by Premier Dental Products Co., cleared under FDA 510(k) K781034 on 30 Jun 1978, active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781034 Date30 Jun 1978ClearedStatusActive

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  • Withdrawn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
EKI
Device class
Class I
Regulation
21 CFR Part 872.4565
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code EKI (Carrier, Amalgam, Operative).

Other devices from Premier Dental Products Company

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