Cleared Traditional

K983105 - CCS

Also marketed or referenced as:
COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01

K983105 is an FDA 510(k) clearance for CCS, manufactured by Dentsply Midwest. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K983105 · Dentsply Midwest · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
185d
Days
Class 2
Risk

K983105 is an FDA 510(k) clearance for the CCS. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Dentsply Midwest (Des Plaines, US). The FDA issued a Cleared decision on March 8, 1999 after a review of 185 days - an extended review 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: 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.

FDA 510(k) Submission Details - K983105

510(k) Number K983105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1998
Decision Date March 08, 1999
Days to Decision 185 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 128d · This submission: 185d
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 37
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K983105.
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
WAND PLUS
K992819 · Spintech, Inc. · May 2000
MINIJECT
K991888 · Spartan Ultrasonics, Inc. · Aug 1999
GETTIG STYRL-JECT DELIVERY SYSTEM
K972285 · Gettig Pharmaceutical Instrument Co. · Sep 1997
SAFETY INJECTION SYSTEM
K962999 · Integritech, Inc. · Jan 1997
SUBLIMINATOR
K961457 · Healex Products, Inc. · Jul 1996
K983105 · CCS
Download PDF FDA Summary Dentsply Midwest