510(k) K013993
- Device
- NEOCALEX
- Applicant
- Stephen M Koral, Dmd
- 510(k) number
- K013993
- Product code
- EIK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-22
- Date received
- 2001-12-04
- Regulation
- 872.4565
- Classification name
- Carver, Wax, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- STEPHEN M KORAL
- Address
- 2006 Broadway Boulder CO US 80302 80302
FDA Registration Numbers#
- 3013552516
- 9610612
- 3014334038
- 3015512299
- 8010704
- 3010442693
- 3001297506
- 2431166
- 2241860
- 3005809810
- 8010159
- 3005067367
- 3007064566
- 3015895045
- 3007751820
- 3004992978
- 3002808270
- 1416675
- 3009703496
- 1422507
- 2246990
- 3019404837
- 3002769835
- 5906
- 1215305
- 8040179
- 3009171220
- 3010055973
- 9611112
- 2511556
- 3011632
- 3014937043
- 8043622
- 9613083
- 3035708926
- 3004598675
- 3001146947
- 8040881
- 3003407244
- 3010288346
- 3027556548
- 9681622
- 3013358456
- 9611367
- 8040263
- 3006059835
- 3005440795
- 8040278
- 3008808049
- 1032227
- 2080222
- 9680735
- 3008338766
- 3003418325
- 1836161
- 3017352116
- 2521453
- 1044031
- 3009340886
- 3012101664
- 3022862651
- 3029082594
- 2916714
- 9611283
- 3002769844
- 3004892425
- 3008770252
- 3003334541
- 3003963832
- 2183301
- 3011499367
- 8010099
- 8041151
- 3005897698
- 3003956316
- 9612086
- 3002834291
- 3001620590
- 3014829979
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EIK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972642 | PERIO CONTROL II | Estrad B.V. | 1998-01-26 |
| K902653 | PDS-2000 | Intl. Equipment and Supply Corp. | 1990-09-13 |
| K860817 | ROOT CANAL ORGANIZER | Pacific Union Dental, Inc. | 1986-03-17 |
| K851727 | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA | Artiberia | 1985-07-02 |