Cleared Traditional

K972485 - CIMPAT N

K972485 is an FDA 510(k) clearance for CIMPAT N, manufactured by Arent, Fox, Kintner, Plotkin & Kahn. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K972485 · Arent, Fox, Kintner, Plotkin & Kahn · Dental device
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Sep 1997
Decision
68d
Days
Class 2
Risk

K972485 is an FDA 510(k) clearance for the CIMPAT N. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Arent, Fox, Kintner, Plotkin & Kahn (Washington, US). The FDA issued a Cleared decision on September 8, 1997 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Arent, Fox, Kintner, Plotkin & Kahn devices

FDA 510(k) Submission Details - K972485

510(k) Number K972485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1997
Decision Date September 08, 1997
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 396
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K972485.
STERI-OSS UNTIL IMPLANT CEMENT
K972965 · Steri-Oss, Inc. · Nov 1997
TEMP BOND CLEAR
K972844 · Kerr Dental Materials Center · Oct 1997
PULPDENT OX-OUT
K972445 · Pulpdent Corp. · Oct 1997
DENTALIS KEZ ENDODONITC SEALER
K971642 · Neodental Chemical Products Co., Ltd. · Jul 1997
HI DENSE TC
K971927 · Shofu Dental Corp. · Jun 1997
TEMPOCEM NE (MULTIPLE)
K970774 · Foremost Dental Mfg., Inc. · Jun 1997