Cleared Traditional

K853091 - CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE

K853091 is an FDA 510(k) clearance for CARDCHEM AQUASET, manufactured by Psp Dental Co., Ltd.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K853091 · Psp Dental Co., Ltd. · Dental device
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Jan 1986
Decision
182d
Days
Class 2
Risk

K853091 is an FDA 510(k) clearance for the CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Psp Dental Co., Ltd. (Belvedere, Kent, GB). The FDA issued a Cleared decision on January 21, 1986 after a review of 182 days - an extended review 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: 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 Psp Dental Co., Ltd. devices

FDA 510(k) Submission Details - K853091

510(k) Number K853091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date January 21, 1986
Days to Decision 182 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 128d · This submission: 182d
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 438
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K853091.
SHOFU LINING CEMENT
K862280 · Shofu Dental Corp. · Jun 1986
GLASIONOMER BASE CEMENT
K861005 · Shofu Dental Corp. · Apr 1986
PANAVIA EX, A DENTAL ADHESIVE
K855211 · Kuraray Co. · Mar 1986
ZIONOMER CEMENT
K852196 · Den-Mat Corp. · Jun 1985
76 EMA LINING CEMENT
K851468 · G-C Intl. Corp. · May 1985
GLAS IONOMER CEMENT
K850913 · Shofu Dental Corp. · Apr 1985