510(k) K950121
- Device
- FRANCE ORTHODONTIE
- Applicant
- FRANCE ORTHODONTIE
- 510(k) number
- K950121
- Product code
- DZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-08
- Date received
- 1995-01-12
- Regulation
- 872.5500
- Classification name
- Headgear, Extraoral, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- BERNARD FONDEUR
- Address
- 18 Rue Galpin-Thiou Tours FR
FDA Registration Numbers
- 3001561923
- 3008959419
- 3009827000
- 3004077103
- 3010236732
- 9710113
- 3015272949
- 3001778198
- 1000118628
- 3008959450
- 9680845
- 9611458
- 1718476
- 2024980
- 2126683
- 3008524225
- 1316408
- 3032027578
- 3016543896
- 2183301
- 2029096
- 3012477813
- 3012421607
- 1833132
- 2081322
- 3003948427
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DZB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202855 | Orthodontic Facemask | Ita.O Italian Orthodontic System S.R.L. | 2021-06-21 |
| K162543 | Reverse Pull Adjustable Facemask | Sawbros Industries Pvt., Ltd. | 2017-08-28 |
| K111169 | PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF | Kwang Myung Daicom, Inc. | 2011-10-03 |
| K103019 | KJ MASK | Kj Meditech Co., Ltd. | 2011-06-09 |
| K052553 | NITOM LOCKING FACEBOW | Russell Samuels Orthodontic Design | 2005-12-22 |
| K051751 | EQUA-PULL SAFETY RELEASE MODULE | Ortho Technology | 2005-07-22 |
| K041718 | KELES FACEMASK | Great Lakes Orthodontics, Ltd. | 2004-10-15 |
| K032392 | MORALES PROTRACTION FACEMASK | Ortosim, S.A. DE C.V. | 2003-10-22 |
| K000358 | MULTI ADJUSTABLE FACE MASK | Ortho Technology | 2000-06-09 |
| K993224 | T-GEAR, MODEL TG/400-700 | Dontech Products B.V. | 2000-02-11 |
| K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | Ortho Kinetics Corp. | 1998-09-04 |
| K980436 | CLASS III REVERSE PULL FACEMASK | Ortho Kinetics Corp. | 1998-04-27 |
| K980245 | NITOM LOCKING FACEBOW | Ortho Kinetics Corp. | 1998-04-21 |
| K980151 | RELEASABLE FORCE MODULE | Ortho Kinetics Corp. | 1998-04-06 |
| K980195 | FACEBOW | Ortho Kinetics Corp. | 1998-03-11 |
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases