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510(k) K781034

PREMIER INLAY PLACER by Premier Dental Products Co. — Product Code EKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1978
Date Received
June 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carrier, Amalgam, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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Other clearances for product code EKI

  • K945220 — AMALGAM CARRIER (January 11, 1995)