510(k) K023367
- Device
- DETECTAR, MODEL N123-MI
- Applicant
- NEKS TECHNOLOGIES
- 510(k) number
- K023367
- Product code
- EJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-06-25
- Date received
- 2002-10-08
- Regulation
- 872.4565
- Classification name
- Handle, Instrument, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES H KYPER
- Address
- 103 Nolen Ln. Chapel Hill NC US 27516 27516
FDA Registration Numbers#
- 3009888740
- 9613083
- 3002834291
- 3007255375
- 8032033
- 3005440795
- 8010445
- 1419247
- 3008496301
- 1835998
- 3001297506
- 1057946
- 3008388427
- 3003622434
- 3003882387
- 3004168759
- 2518634
- 3043239665
- 3017399129
- 3043648115
- 3004149679
- 2431166
- 3010328449
- 3003882399
- 3006891796
- 3005665377
- 9611458
- 3003184527
- 1450653
- 1066741
- 3008338766
- 3008493350
- 8040263
- 9611367
- 3015276580
- 3009528826
- 3022862651
- 3007958831
- 3008887731
- 3016965929
- 3015128224
- 3005092287
- 3003418325
- 1032347
- 3009325911
- 3004892425
- 3015397788
- 3002090132
- 3008808049
- 3005972890
- 3038718579
- 3015895045
- 3010353847
- 2018957
- 3003963832
- 3003449480
- 2521453
- 3003491259
- 1410097
- 3030126955
- 3002769835
- 8021059
- 3003877407
- 8030870
- 3002769844
- 9614075
- 2086043
- 3006990004
- 3011526299
- 2246990
- 9610905
- 1421879
- 3009307523
- 3001146947
- 3006550126
- 8043992
- 3022516928
- 3002675176
- 3009968482
- 3027556548
Source Documents#
Other 510(k) Records For Product Code EJB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140144 | BENDA WEDGE | Centrix, Inc. | 2014-07-08 |
| K981234 | FLARE,FILE, FILL | Lone Star Technologies | 1998-06-05 |
| K930094 | AUKUSLEEVE | Aukland Medical Plastics, Inc. | 1993-10-20 |
| K922633 | CAVI-ZYME | E&D Dental Products, Inc. | 1992-08-06 |
| K871818 | SPATULA, DENTAL, CEMENT | Military Engineering, Inc. | 1987-07-02 |
| K833338 | TOOTH SLOOTH | Joel Lander D.D.S. | 1983-11-25 |
| K823913 | SOFT GRIP UNI-HANDLE | Treace Medical, Inc. | 1983-01-26 |
Legacy Summary#
summary
FDA Review#
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