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510(k) K001108

PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL by Prime Dental Manufacturing, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2000
Date Received
April 5, 2000
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.

  • K112574 — PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT (January 23, 2012)
  • 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)
  • K994224 — PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL (January 31, 2000)

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