Cleared Traditional

K000710 - MD 10, SEM, SM 12, CBM

K000710 is an FDA 510(k) clearance for MD 10, manufactured by NOUVAG AG. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K000710 · NOUVAG AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
70d
Days
Class 1
Risk

K000710 is an FDA 510(k) clearance for the MD 10, SEM, SM 12, CBM. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by NOUVAG AG (Kaufbeuren, DE). The FDA issued a Cleared decision on May 11, 2000 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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.

FDA 510(k) Submission Details - K000710

510(k) Number K000710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2000
Decision Date May 11, 2000
Days to Decision 70 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
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 240
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K000710.
CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO
K000834 · Castellini S.P.A. · Dec 2000
TDK HANDPIECES
K000848 · Orasystems · Oct 2000
ORALUBE
K000847 · Orasystems · Sep 2000
ATR TECNIKA
K000547 · Advanced Technology Research (A.T.R.) S.R.P. · May 2000
SUNI MAX
K000049 · Satelec · Apr 2000
DENTAL HANDPIECE
K971732 · Pauline M. Nicholls · Jan 2000
K000710 · MD 10, SEM, SM 12, CBM
Download PDF FDA Summary NOUVAG AG