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510(k) K905155

HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES by Star Dental Mfg. Co. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1991
Date Received
November 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Star Dental Mfg. Co.

  • K782007 — ROTARY SCALER (January 3, 1979)
  • K781281 — CEMENT, DENTAL/CAVITY LINER (August 21, 1978)
  • K771246 — ALARM SYS FOR NITROUS OXIDE SYS. (July 15, 1977)
  • K771247 — CORE MATERIAL (July 15, 1977)

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