Cleared Traditional

K983242 - SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES

K983242 is an FDA 510(k) clearance for SIRONA C8 DENTAL OPERATIVE UNIT WITH AC..., manufactured by Sirona Dental Systems GmbH. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K983242 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
86d
Days
Class 1
Risk

K983242 is an FDA 510(k) clearance for the SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sirona Dental Systems GmbH (North Attleboro, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Sirona Dental Systems GmbH devices

FDA 510(k) Submission Details - K983242

510(k) Number K983242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1998
Decision Date December 11, 1998
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 178
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K983242.
S555 INTRAORAL DENTAL CAMERA
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PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE
K983731 · Pall Medical · Dec 1998
ERADIC-ALL
K981171 · Theratechnologies, Inc. · Dec 1998
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
K983847 · Germiphene Corp. · Dec 1998
BIO-2000
K973765 · Micrylium Laboratories · Nov 1998