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510(k) K010415

ISODAN by Specialites Septodont — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2001
Date Received
February 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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  • K915467 — CIMPAT S DENTAL CEMENT (February 3, 1992)
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  • K913572 — AUTOPACK NON-EUGENOL PERIODONTAL DRESSING (October 9, 1991)
  • K913574 — SEPTOCAL CAVITY LINER (September 30, 1991)

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