Orthoslenderizer

FDA 510(k) K111249 · Orthomatics, Inc.

Substantially Equivalent

510(k) numberK111249

Submission

Device name
Orthoslenderizer
Applicant
Orthomatics, Inc.
Highlands Ranch, CO, US
Received
May 3, 2011
Decision date
February 8, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

Other 510(k)s with product code EFB

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K242179Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional W&H Dentalwerk Bürmoos GmbH02/28/2025SE
K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional Guangdong Jinme Medical Technology Co., Ltd.11/13/2024SE
K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional Foshan Soco Precision Instrument Co., Ltd.11/12/2024SE
K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional Nakanishi, Inc.09/20/2024SE
K233122High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional Litu Tech , Ltd.04/30/2024SE
K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional Nakanishi, Inc.04/25/2024SE
K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional Foshan Coxo Medical Instrument Co., Ltd.09/22/2023SE
K232243EVO 700 series high speed handpieceEFB · Special Ttbio Corp.08/23/2023SE

Questions and answers

When was Orthoslenderizer cleared by the FDA?

Orthoslenderizer (K111249) received a 510(k) decision of Substantially Equivalent on February 8, 2012, 281 days after the submission was received.

What is the product code of K111249?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.