Cleared Traditional

K980953 - ACCU-BITE HOME KIT DISCLUDER

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

FDA 510(k) Submission Details - K980953

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 127d · This submission: 208d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -