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510(k) K935713

WILEY/ESPOSITO DENTAL GUARD by Fvtnks — Product Code BRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1994
Date Received
November 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Dental
Device Class
Class I
Regulation Number
868.5820
Review Panel
AN
Submission Type

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Other clearances for product code BRW

  • K945727 — CATCO NEONATAL PALATE GUARD (December 7, 1994)
  • K851640 — TIP TOLEDO INCISOR PROTECTOR (September 18, 1985)