Cleared Traditional

K011061 - SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11

K011061 is an FDA 510(k) clearance for SURGICAL CONTRA-ANGEL HANDPIECES TYPES ..., manufactured by W&H Dentalwerk Buermoos GmbH. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K011061 · W&H Dentalwerk Buermoos GmbH · Dental device
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Jun 2001
Decision
83d
Days
Class 1
Risk

K011061 is an FDA 510(k) clearance for the SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL ST.... Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on June 28, 2001 after a review of 83 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.

View all W&H Dentalwerk Buermoos GmbH devices

FDA 510(k) Submission Details - K011061

510(k) Number K011061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2001
Decision Date June 28, 2001
Days to Decision 83 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
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, 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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 52
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K011061.
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
K022505 · NOUVAG AG · Oct 2003
CLEAN 'N' OIL
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AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
K020137 · Aseptico, Inc. · Mar 2002
EXTENDED STRAIGHT ATTACHMENT
K994024 · Team Technologies, Inc. · Feb 2000
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
K983574 · Dentalez Group · Jan 1999
23:1 REDUCTION ANGLE
K973800 · Midwest Dental Products Corp. · Mar 1998