Home / 510(k) Clearances / K983227

510(k) K983227

POWER BLOCK by Kreativ, Inc. — Product Code EIE

K983227 is an FDA 510(k) premarket notification submitted by Kreativ, Inc. for the device "POWER BLOCK". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Kreativ, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
September 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

Other clearances by Kreativ, Inc.

  • K990060 — MACH 7 (June 15, 2000)
  • K980216 — KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 (June 16, 1998)
  • K962376 — KREATIV KURING LIGHT SYSTEM (March 21, 1997)
  • K940776 — KREATIV MODEL KV-1 (December 21, 1994)

Other clearances for product code EIE

  • K182118 — armor LC (May 3, 2019)
  • K151945 — Triumph Resin Dam (February 18, 2016)
  • K050318 — BARI-KAD PACKING DEVICE (March 4, 2005)
  • K043301 — GC TION GINGIVAL PROTECTOR (January 25, 2005)
  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)
  • K022522 — PULPDENT PUTTY DAM (September 26, 2002)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 2002)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K972775 — FASTDAM (February 27, 1998)

FDA data resources