Cleared Traditional

K970992 - PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS

K970992 is an FDA 510(k) clearance for PREMIER NITROSPRAY PLUS AND PREMIER NIT..., manufactured by Premier Dental Products Co.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K970992 · Premier Dental Products Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
90d
Days
Class 2
Risk

K970992 is an FDA 510(k) clearance for the PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Premier Dental Products Co. (King Of Prussia, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Premier Dental Products Co. devices

FDA 510(k) Submission Details - K970992

510(k) Number K970992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1997
Decision Date June 17, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 137
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K970992.
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
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HISTOFREEZER VERRUCA PLANA
K971392 · OraSure Technologies, Inc. · Oct 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
K963970 · Endocare, Inc. · Feb 1997
ENDOCARE CRYCARE CRYOSURGICAL SYSTEM
K963826 · Endocare, Inc. · Dec 1996
PERCUTANEOUS INTRODUCER SYSTEM
K961219 · Boston Scientific Corp · Jun 1996