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510(k) K945220

AMALGAM CARRIER by Buffalo Dental Mfg. Co., Inc. — Product Code EKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1995
Date Received
October 26, 1994
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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  • K802662 — POLYCARBONATE TEMPORARY CEMENT (December 16, 1980)

Other clearances for product code EKI

  • K781034 — PREMIER INLAY PLACER (June 30, 1978)