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#
- 3005497907
- 1410097
- 2029275
- 9614986
- 1281412
- 9610612
- 3003600526
- 2134751
- 3015422158
- 3009170227
- 3014334038
- 3015512299
- 3010442693
- 3013538161
- 3006990004
- 3001297506
- 3038632739
- 3022378059
- 3009161350
- 3027615
- 1419982
- 3016954909
- 2431166
- 3006847937
- 3006540014
- 2086043
- 3005809810
- 3010147274
- 1723412
- 8010159
- 3013557697
- 2029234
- 3009255580
- 3017399129
- 3036795921
- 2433629
- 3015548849
- 3010303097
- 8044098
- 3008831210
- 3005067367
- 3006694515
- 3009968482
- 3009049852
- 1421101
- 3015895045
- 3004730002
- 3043648115
- 3017604
- 3021963363
- 3008388427
- 3008960188
- 8010445
- 2081322
- 3007751820
- 3005665377
- 3011936113
- 2918719
- 3002808270
- 9613953
- 3005277354
- 3001949270
- 3008323540
- 3009703496
- 3011554142
- 3003882399
- 1422507
- 3019404837
- 2246990
- 3003449480
- 3002769835
- 1032347
- 3004417597
- 8030938
- 1057425
- 5906
- 9611827
- 9616103
- 3011371465
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#
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