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510(k) K012673

PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM by Prime Dental Manufacturing, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2001
Date Received
August 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

Other clearances by Prime Dental Manufacturing, Inc.

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  • 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)
  • 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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