Cleared Traditional

K960270 - DENTALOGIC

K960270 is an FDA 510(k) clearance for DENTALOGIC, manufactured by Protecs Syringes International Corp.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K960270 · Protecs Syringes International Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
57d
Days
Class 2
Risk

K960270 is an FDA 510(k) clearance for the DENTALOGIC. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Protecs Syringes International Corp. (Palm Harobor, US). The FDA issued a Cleared decision on March 15, 1996 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - 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 Protecs Syringes International Corp. devices

FDA 510(k) Submission Details - K960270

510(k) Number K960270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1996
Decision Date March 15, 1996
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJI Device Classification - Class 2, Special Controls

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
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 - EJI Syringe, Cartridge

All 17
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K960270.
SAFETY INJECTION SYSTEM
K962999 · Integritech, Inc. · Jan 1997
SUBLIMINATOR
K961457 · Healex Products, Inc. · Jul 1996
THE WAND
K961648 · Spintech, Inc. · Jul 1996
EAGLE
K950309 · Aalba Dent, Inc. · Feb 1995
IMPULSE SEALER PRODUCT LINE
K943370 · Ultradent Products, Inc. · Oct 1994
CITOJECT CARTRIDGE SYRINGE
K842006 · Miles Laboratories, Inc. · Jul 1984