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#
- 2433629
- 3022516928
- 5906
- 1057946
- 3011625373
- 3015422158
- 3005972890
- 3027556548
- 3004149679
- 1924066
- 3043239665
- 8040179
- 3025338240
- 3009325911
- 9612075
- 3005061536
- 3013557697
- 3036795921
- 3002807115
- 3005497907
- 3039414397
- 3014829979
- 1032347
- 3027615
- 2029234
- 1835998
- 3017399129
- 9616103
- 9613083
- 3003399181
- 1421879
- 3015276580
- 3011526299
- 3001084743
- 3015176311
- 8020776
- 3017352116
- 3005515228
- 3044819802
- 8010908
- 3003407244
- 9611367
- 3008496301
- 9610905
- 3021388085
- 2521453
- 9680026
- 1057425
- 3010164069
- 3030183061
- 8010732
- 9611899
- 3003418325
- 3038632739
- 3009170227
- 1836229
- 8043554
- 3009887475
- 3015895045
- 3004168759
- 3012627824
- 3003334541
- 3004158247
- 3013946322
- 3003184527
- 3011600579
- 3010147274
- 3043355002
- 1723412
- 3011554142
- 8044098
- 3007622273
- 8030870
- 3011164188
- 1422507
- 3005831677
- 1833132
- 3008902714
- 3013167159
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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