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510(k) K953628

PROPHY ANGLE by Rolence Enterprise Co. , Ltd. — Product Code EHK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
July 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cup, Prophylaxis
Device Class
Class I
Regulation Number
872.6290
Review Panel
DE
Submission Type

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  • K803155 — PROPHYLAXIS CUP. (January 8, 1981)
  • K790723 — PROPHYLAXIS CUPS AND POLISHERS (June 15, 1979)
  • K780198 — PROPHY CUPS, R&R (February 16, 1978)
  • K770556 — PRO-KUP (March 24, 1977)