Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4200](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4200) → EFA — Handpiece, Belt And/Or Gear Driven, Dental # EFA · Handpiece, Belt And/Or Gear Driven, Dental _Dental · 21 CFR 872.4200 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA ## Overview - **Product Code:** EFA - **Device Name:** Handpiece, Belt And/Or Gear Driven, Dental - **Regulation:** [21 CFR 872.4200](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4200) - **Device Class:** 1 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. ## Classification Rationale Class I. ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K192809](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K192809.md) | Dental Handpiece | Micro-Nx Co., Ltd. | Aug 25, 2020 | SESE | | [K163239](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K163239.md) | SMARTmatic | Kaltenbach & Voigt GmbH | Mar 17, 2017 | SESE | | [K143465](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K143465.md) | MASTERmatic LUX | Kaltenbach & Voigt GmbH | Apr 9, 2015 | SESE | | [K101172](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K101172.md) | RDT3 HANDPIECE HEAD MODEL RDT3 | Redent Nova, Ltd. | Jul 27, 2010 | SESE | | [K093894](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K093894.md) | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | Anthogyr | Mar 3, 2010 | SESE | | [K092446](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K092446.md) | INTRA LUX HEAD 3 LDSY | Kaltenbach & Voigt GmbH & Co. | Nov 3, 2009 | SESE | | [K090055](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K090055.md) | LOW & HIGH SPEED KIT | Dpm USA Corp. | Oct 27, 2009 | SESE | | [K092412](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K092412.md) | STRONG IMPLANT HANDPIECES | Saeshin Precision Co., Ltd. | Sep 3, 2009 | SESE | | [K090676](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K090676.md) | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | Anthogyr | May 22, 2009 | SESE | | [K070084](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K070084.md) | MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL | Est. Anthogyr | Mar 8, 2007 | SESE | | [K061701](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K061701.md) | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | J. Morita USA, Inc. | Aug 25, 2006 | SESE | | [K061581](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K061581.md) | EXCEL HIGH SPEED DENTAL HANDPIECE | Orthosource, Inc. | Aug 16, 2006 | SESE | | [K040674](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K040674.md) | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | Anthogyr | Jun 30, 2004 | SESE | | [K013185](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K013185.md) | TCM ENDO III | NOUVAG AG | Nov 28, 2001 | SESE | | [K002709](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K002709.md) | RACE ENDODONTIC FILE | Amc General, Inc. | Nov 17, 2000 | SESE | | [K973062](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K973062.md) | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE | Medidenta Intl., Inc. | Oct 9, 1997 | SESE | | [K971603](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K971603.md) | STERILE SUREFLEX FILES AND INSTRUMENTS | Dentsply Intl. | Jun 4, 1997 | SESE | | [K971606](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K971606.md) | STERILE FLEXOFILE FILES AND INSTRUMENTS | Dentsply Intl. | Jun 3, 1997 | SESE | | [K965238](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K965238.md) | T1 CONTROL HIGH SPEED DENTAL HANDPIECE | Siemens AG | Mar 19, 1997 | SESE | | [K960719](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K960719.md) | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE | Dentalez Group | Mar 28, 1996 | SESE | ## Top Applicants - Anthogyr — 3 clearances - Dentalez Group — 3 clearances - Dentsply Intl. — 2 clearances - J. Morita USA, Inc. — 2 clearances - Kaltenbach & Voigt GmbH — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com