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510(k) K112574

PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT by Prime Dental Manufacturing, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2012
Date Received
September 6, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Prime Dental Manufacturing, Inc.

  • K022675 — PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL (November 7, 2002)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 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)

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