Cleared Traditional

K972775 - FASTDAM

K972775 is an FDA 510(k) clearance for FASTDAM, manufactured by Interdent, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K972775 · Interdent, Inc. · Dental device
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Feb 1998
Decision
218d
Days
Class 1
Risk

K972775 is an FDA 510(k) clearance for the FASTDAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Interdent, Inc. (Los Angeles, US). The FDA issued a Cleared decision on February 27, 1998 after a review of 218 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - the FDA dental device regulatory framework. 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 Interdent, Inc. devices

FDA 510(k) Submission Details - K972775

510(k) Number K972775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date February 27, 1998
Days to Decision 218 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
91d slower than avg
Panel avg: 127d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIE Dam, Rubber

All 13
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K972775.
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
NIVEOUS LIQUID DAM
K021613 · Shofu Dental Corp. · Jun 2002
POWER BLOCK
K983227 · Kreativ, Inc. · Dec 1998
DENTAL DAM SILICONE
K961472 · Worldwide Dental, Inc. · Aug 1996
DENTAL DAM
K954990 · The Hygenic Corp. · Jan 1996
DENTAL RUBBER DAM
K923157 · Aseptico, Inc. · Jul 1993