Home / 510(k) Clearances / K021524

510(k) K021524

LIGHT CURE DENTAL DAM by Prime Dental Manufacturing, Inc. — Product Code EIE

K021524 is an FDA 510(k) premarket notification submitted by Prime Dental Manufacturing, Inc. for the device "LIGHT CURE DENTAL DAM". The FDA issued a decision of Substantially Equivalent on July 19, 2002. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Prime Dental Manufacturing, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2002
Date Received
May 10, 2002
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 Prime Dental Manufacturing, Inc.

  • K112574 — PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT (January 23, 2012)
  • K022675 — PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL (November 7, 2002)
  • K013970 — PRIME-DENT HEMA DESENSITIZER (February 19, 2002)
  • K012794 — PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT (November 5, 2001)
  • K012761 — PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT (November 1, 2001)
  • K012673 — PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM (October 24, 2001)
  • K001108 — PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL (May 30, 2000)
  • K994224 — PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL (January 31, 2000)

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)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K983227 — POWER BLOCK (December 11, 1998)
  • K972775 — FASTDAM (February 27, 1998)

FDA data resources