510(k) K092446
- Device
- INTRA LUX HEAD 3 LDSY
- Applicant
- KALTENBACH & VOIGT GMBH & CO.
- 510(k) number
- K092446
- Product code
- EFA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-03
- Date received
- 2009-08-10
- Regulation
- 872.4200
- Classification name
- Handpiece, Belt And/or Gear Driven, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CLAUDIA ORTIZ
- Address
- 1717 W. Collins Orange CA US 92867 92867
FDA Registration Numbers#
- 3004884150
- 3007958831
- 3007345485
- 2024312
- 3015729
- 1722638
- 1063774
- 3011300255
- 9681479
- 3012477813
- 2916440
- 3003637274
- 3010281549
- 3002807636
- 2032112
- 1319130
- 8020776
- 3012494290
- 9614977
Source Documents#
Other 510(k) Records For Product Code EFA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020-08-25 |
| K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | 2017-03-17 |
| K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | 2015-04-09 |
| K101172 | RDT3 HANDPIECE HEAD MODEL RDT3 | Redent Nova, Ltd. | 2010-07-27 |
| K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | Anthogyr | 2010-03-03 |
| K090055 | LOW & HIGH SPEED KIT | Dpm USA Corp. | 2009-10-27 |
| K092412 | STRONG IMPLANT HANDPIECES | Saeshin Precision Co., Ltd. | 2009-09-03 |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | Anthogyr | 2009-05-22 |
| K070084 | MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL | Est. Anthogyr | 2007-03-08 |
| K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | J. Morita USA, Inc. | 2006-08-25 |
| K061581 | EXCEL HIGH SPEED DENTAL HANDPIECE | Orthosource, Inc. | 2006-08-16 |
| K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | Anthogyr | 2004-06-30 |
| K013185 | TCM ENDO III | NOUVAG AG | 2001-11-28 |
| K002709 | RACE ENDODONTIC FILE | Amc General, Inc. | 2000-11-17 |
| K973062 | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE | Medidenta Intl., Inc. | 1997-10-09 |
Legacy Summary#
summary
FDA Review#
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