510(k) K012303
- Device
- JEL-20
- Applicant
- J.F. JELENKO & CO., INC.
- 510(k) number
- K012303
- Product code
- EJS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-22
- Date received
- 2001-07-20
- Regulation
- 872.3060
- Classification name
- Alloy, Other Noble Metal
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAPHAEL JUDKINS
- Address
- 99 Business Park Dr. Armonk NY US 10504 10504
FDA Registration Numbers#
- 3001561923
- 3005176727
- 3040605150
- 3004578725
- 3010152557
- 3003893092
- 3009496224
- 3035335007
- 3033085428
- 3008155930
- 1219645
- 3013551048
- 3008317118
- 1316092
- 9611458
- 3014368926
- 3017903664
- 1718476
- 3005172141
- 2023817
- 2024980
- 3031606428
- 8031058
- 3043303267
- 3034729565
- 3003103749
- 3008320092
- 3013546336
- 3004726107
- 2433919
- 3006191485
- 3032027578
- 3006115130
- 3012341864
- 3009482106
- 3005181866
- 3009300369
- 2183301
- 3008727912
- 2916734
- 3011170140
- 9611514
- 2921595
- 3019909974
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EJS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041433 | BRIGHT GOLD XH | Ivoclar Vivadent, Inc. | 2004-08-19 |
| K040436 | SIMIDUR SUPERIOR | Wieland Dental + Technik GmbH & Co. KG | 2004-03-05 |
| K022252 | STERNGOLD 1, MODEL 1127781 | Sterngold | 2002-09-19 |
| K022469 | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 |
| K021367 | STERNGOLD 66, MODEL #1180230 | Sterngold | 2002-05-16 |
| K020192 | SIMIDUR S2 | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| K020194 | SIMIDUR KF PLUS | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| K020195 | SIMIDUR S1S | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| K014042 | D.SIGN 84 | Ivoclar Vivadent, Inc. | 2002-02-22 |
| K013809 | D.SIGN 59 | Ivoclar Vivadent, Inc. | 2002-02-07 |
| K014082 | D.SIGN 53, MODEL NA1012204 | Ivoclar Vivadent, Inc. | 2002-01-30 |
| K012841 | DUO PAL 6, ORDER-NO.: 2154 | Wieland Edelmetalle GmbH & Co. | 2001-11-20 |
| K012828 | PORTA SMK 82, MODEL 2032 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| K012840 | EURO 45, ORDER-NO.: 2064 | Wieland Edelmetalle GmbH & Co. | 2001-10-23 |
| K003632 | DW 273 #1 | Ivoclar North America, Inc. | 2000-12-20 |
Legacy Summary#
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FDA Review#
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