510(k) K831098
- Device
- DOMINION
- Applicant
- UNITEK CORP.
- 510(k) number
- K831098
- Product code
- EJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-16
- Date received
- 1983-04-04
- Regulation
- 872.3060
- Classification name
- Alloy, Gold-based Noble Metal
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3040605150
- 3004578725
- 3010152557
- 3009496224
- 3035335007
- 3030154803
- 3033085428
- 3008155930
- 1219645
- 3013551048
- 3030254056
- 3003929447
- 1316092
- 3014368926
- 3017903664
- 8031058
- 2023817
- 3043303267
- 3006459726
- 3013546336
- 9681199
- 3005344553
- 3016998377
- 3012341864
- 3004491043
- 3011824442
- 3005181866
- 3009300369
- 3011500388
- 3008727912
- 3007740664
- 3006059056
- 3016986305
- 2916734
- 3011170140
- 3016117382
- 3021432364
- 3004905070
- 9611514
- 2921595
- 3019909974
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EJT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052463 | PROMETAL HN86 | Prometal Technologies | 2005-10-14 |
| K041378 | BIO 60 | Kodent, Inc. | 2004-08-02 |
| K040672 | PORTA REFLEX | Wieland Dental + Technik GmbH & Co. KG | 2004-05-27 |
| K040524 | PORTA SOLDER 1090 W | Wieland Dental + Technik GmbH & Co. KG | 2004-05-20 |
| K040043 | NDX-40 ALLOY | Heraeus Kulzer, Inc. | 2004-03-03 |
| K034049 | HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM | Heraeus Kulzer,GmbH | 2004-03-01 |
| K033279 | GOLD DENTAL CASTING ALLOYS | Bego U.S.A. | 2004-01-15 |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-13 |
| K033435 | E-SARANG 86, DM78, DM55 | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| K032320 | APPOLLO 3 ALLOY | Dentsply International | 2003-10-01 |
| K032321 | CERA F ALLOY | Dentsply International | 2003-09-30 |
| K032319 | CERA R PLUS ALLOY | Dentsply International | 2003-09-30 |
| K032318 | MINERVA 58 ALLOY | Dentsply International | 2003-09-30 |
| K032317 | ORION GX ALLOY | Dentsply Intl. | 2003-09-30 |
| K032316 | ORION E ALLOY | Dentsply Intl. | 2003-09-30 |
Legacy Summary#
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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