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510(k) K953628

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

K953628 is an FDA 510(k) premarket notification submitted by Rolence Enterprise Co. , Ltd. for the device "PROPHY ANGLE". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code EHK (Cup, Prophylaxis), a Class I device regulated under 21 CFR 872.6290. Rolence Enterprise Co. , Ltd. has at least 10 other 510(k) clearances on record.

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

Other clearances by Rolence Enterprise Co. , Ltd.

  • K001719 — Q-LUX PLASMA 100 LIGHT CURE UNIT (October 10, 2000)
  • K991865 — Q-LITE 75 LIGHT CURE UNIT (July 20, 1999)
  • K991863 — CUTE-LITE I LIGHT CURE UNIT (July 19, 1999)
  • K980792 — CU-100A LIGHT CURE UNIT (May 15, 1998)
  • K980793 — Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT (May 15, 1998)
  • K960351 — Q-LUX LIGHT CURE UNIT (April 15, 1996)
  • K960364 — CU-200 LIGHT CURE UNIT (April 15, 1996)
  • K952423 — CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 (June 22, 1995)
  • K942199 — CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 (June 2, 1994)
  • K942198 — CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 (May 27, 1994)

Other clearances for product code EHK

  • K951016 — DISPOSABLE PROPHYLAXIS ANGLE (May 2, 1995)
  • K900507 — DISPOSABLE SCREW TYPE PROPHY BRUSH (April 10, 1990)
  • K864059 — DENTAL PROPHY CUPS (VARIOUS TYPES) (November 19, 1986)
  • 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)

FDA data resources