Cleared Traditional

K022522 - PULPDENT PUTTY DAM

K022522 is an FDA 510(k) clearance for PULPDENT PUTTY DAM, manufactured by Pulpdent Corporation. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K022522 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
58d
Days
Class 1
Risk

K022522 is an FDA 510(k) clearance for the PULPDENT PUTTY DAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on September 26, 2002 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pulpdent Corporation devices

FDA 510(k) Submission Details - K022522

510(k) Number K022522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2002
Decision Date September 26, 2002
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 127d · This submission: 58d
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 K022522.
Triumph Resin Dam
K151945 · Denali Corporation · Feb 2016
BARI-KAD PACKING DEVICE
K050318 · Bioenvelop Agro, Inc. · Mar 2005
GC TION GINGIVAL PROTECTOR
K043301 · GC America, Inc. · Jan 2005
NIVEOUS LIQUID DAM
K021613 · Shofu Dental Corp. · Jun 2002
POWER BLOCK
K983227 · Kreativ, Inc. · Dec 1998
FASTDAM
K972775 · Interdent, Inc. · Feb 1998