Cleared Traditional

K970827 - PRECISE

K970827 is an FDA 510(k) clearance for PRECISE, manufactured by Allan Schulman,D.D.S., M.S.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K970827 · Allan Schulman,D.D.S., M.S. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
41d
Days
Class 2
Risk

K970827 is an FDA 510(k) clearance for the PRECISE. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Allan Schulman,D.D.S., M.S. (Flushing, US). The FDA issued a Cleared decision on April 16, 1997 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 Allan Schulman,D.D.S., M.S. devices

FDA 510(k) Submission Details - K970827

510(k) Number K970827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1997
Decision Date April 16, 1997
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 97
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K970827.
PLATALLOY
K972607 · Aalba Dent, Inc. · Oct 1997
VERA PDN
K972118 · Aalba Dent, Inc. · Aug 1997
VITALLIUM 2000 ALLOY
K970205 · Austenal, Inc. · Apr 1997
RX 96E
K963891 · Jeneric/Pentron, Inc. · Nov 1996
REMATITAN TITANIUM
K952866 · Dentauraum, Inc. · Jul 1995
REMANIUM:GM 700, GM 380, GM 800, GFH
K952867 · Dentauraum, Inc. · Jul 1995