Cleared Traditional

ACCU-BITE HOME KIT DISCLUDER (K980953) - FDA 510(k) Clearance

K980953 · Jerome M. Simon · Dental device
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Oct 1998
Decision
208d
Days
-
Risk

K980953 is an FDA 510(k) clearance for the ACCU-BITE HOME KIT DISCLUDER. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Jerome M. Simon (Stamford, US). The FDA issued a Cleared decision on October 7, 1998 after a review of 208 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Jerome M. Simon devices

Submission Details

510(k) Number K980953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1998
Decision Date October 07, 1998
Days to Decision 208 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 127d · This submission: 208d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -