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510(k) K022675

PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL by Prime Dental Manufacturing, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2002
Date Received
August 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • 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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