Cleared Traditional

K973370 - AQUAPLAST PALATAL STENT

K973370 is an FDA 510(k) clearance for AQUAPLAST PALATAL STENT, manufactured by Wfr/Aquaplast Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K973370 · Wfr/Aquaplast Corp. · Dental device
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Dec 1997
Decision
85d
Days
Class 2
Risk

K973370 is an FDA 510(k) clearance for the AQUAPLAST PALATAL STENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on December 2, 1997 after a review of 85 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 Wfr/Aquaplast Corp. devices

FDA 510(k) Submission Details - K973370

510(k) Number K973370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date December 02, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
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 300
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K973370.
ADHESIVE HYBRID IONOMER CEMENT
K974140 · Dentsply Intl. · Jan 1998
3M DENT SYSTEM II PLUS
K973961 · 3M Company · Dec 1997
PULPDENT DENTASTIC UNO
K974014 · Pulpdent Corp. · Dec 1997
SYNTAC SPRINT
K973397 · Ivoclar North America, Inc. · Nov 1997
STERI-OSS UNTIL IMPLANT CEMENT
K972965 · Steri-Oss, Inc. · Nov 1997
PULPDENT OX-OUT
K972445 · Pulpdent Corp. · Oct 1997