Jensen Premium Dental Alloy
77 catalogue numbers from JRVT 1ozt, listed by Jensen Industries, Inc., United States, under Alloy, Gold-Based Noble Metal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
77catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (9), Hebei (1), Hong Kong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Fseven Dental Technology Zhuhai Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 18 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Shenzhen HLD Dental&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 14 |
| Shenzhen Times Dental LAB | Shenzhen | Guangdong | Manufacturer | 13 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Crown Trading (HK) Co., Limited | Hong Kong | Hong Kong | Manufacturer | 8 |
| Smart Dental CAD Solutions Limited | Zhuhai | Guangdong | Manufacturer | 8 |
| Vivi Dental Laboratory | Shenzhen | Guangdong | Manufacturer | 8 |
Record
| Listed by | Jensen Industries, Inc., United States |
|---|---|
| FDA product code | EJT |
| Device type | Alloy, Gold-Based Noble Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JRVT 1ozt | In distribution | |
| GALILEO 1ozt | In distribution | |
| JCB 10dwt | In distribution | |
| J-22 32 GAUGE 5dwt | In distribution | |
| 650 SLD 5dwt Spool | In distribution | |
| ENDURANCE 1ozt | In distribution | |
| SPIRIT SLD 5dwt | In distribution | |
| EQUITY 1ozt | In distribution | |
| JIV-PF 1ozt | In distribution | |
| JP-II 5dwt | In distribution | |
| JP-I 1ozt | In distribution | |
| JMC 4g | In distribution | |
| AZTEC 1ozt | In distribution | |
| JCB 1ozt | In distribution | |
| JLCB 1ozt | In distribution | |
| J-3 1ozt | In distribution | |
| JRVT-PF 1ozt | In distribution | |
| AZTEC 5dwt | In distribution | |
| JP-II 1ozt | In distribution | |
| SL-40 5dwt | In distribution | |
| JP-80 1ozt | In distribution | |
| PWS SLD 1dwt | In distribution | |
| 615 SLD 5dwt Spool | In distribution | |
| 615 SLD 1dwt | In distribution | |
| JA 5dwt | In distribution | |
| ENDURANCE 5dwt | In distribution | |
| JP-I 5dwt | In distribution | |
| LX SLD 1dwt | In distribution | |
| JRVT 5dwt | In distribution | |
| JCB 5dwt | In distribution | |
| JYE 1ozt | In distribution | |
| VERITY 5dwt | In distribution | |
| CLASSIC IV 5dwt | In distribution | |
| Jensen Gold Foil (3g) | In distribution | |
| J-IV 5dwt | In distribution | |
| VERITY 1oz | In distribution | |
| FOUNDATION 5dwt | In distribution | |
| JPW 5dwt | In distribution | |
| 585 SLD 1dwt | In distribution | |
| J-IV 1ozt | In distribution | |
| JC 1ozt | In distribution | |
| EQUITY 5dwt | In distribution | |
| J-22 32 GAUGE 1ozt | In distribution | |
| SENTRY 5dwt | In distribution | |
| P-80 SLD 1dwt | In distribution | |
| FOUNDATION 1ozt | In distribution | |
| OVERTURE 1ozt | In distribution | |
| J-3 5dwt | In distribution | |
| JCBD 5dwt | In distribution | |
| OVERTURE 4g | In distribution | |
| 650 SLD 1dwt | In distribution | |
| JLCB 5dwt | In distribution | |
| SL-40 1ozt | In distribution | |
| JPW 1ozt | In distribution | |
| CPS SLD 5dwt Spool | In distribution | |
| JMC 1ozt | In distribution | |
| JIV-PF 4g | In distribution | |
| JP-80 5dwt | In distribution | |
| JYE 5dwt | In distribution | |
| OVERTURE 5dwt | In distribution | |
| SPIRIT SLD 1dwt | In distribution | |
| JRVT-PF 5dwt | In distribution | |
| JIV-PF 5dwt | In distribution | |
| JC 5dwt | In distribution | |
| 650 4g | In distribution | |
| CLASSIC IV 1ozt | In distribution | |
| 585 SLD 5dwt Spool | In distribution | |
| ENDURANCE 4g | In distribution | |
| CPS SLD 1dwt | In distribution | |
| P-80 SLD 5dwt Spool | In distribution | |
| J-22 31 GAUGE 1ozt | In distribution | |
| SENTRY 1ozt | In distribution | |
| J-22 32 GAUGE 10dwt | In distribution | |
| JA 1ozt | In distribution | |
| PWS SLD 5dwt Spool | In distribution | |
| JCBD 1ozt | In distribution | |
| JMC 5dwt | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ceramco® | Dentsply LLC | 21 |
| Windsor | Aurident, Inc. | 10 |
| RH | Aurident, Inc. | 10 |
| Elite II | Aurident, Inc. | 10 |
| Auritex WP | Aurident, Inc. | 10 |
| Auritex LP | Aurident, Inc. | 10 |
| Auritex KP | Aurident, Inc. | 10 |
| Auribond 97 | Aurident, Inc. | 10 |
| EH | Aurident, Inc. | 10 |
| Auritex 66 | Aurident, Inc. | 10 |
| WH | Aurident, Inc. | 10 |
| Auritex 40 | Aurident, Inc. | 10 |
Showing 12 of 398. All products under Alloy, Gold-Based Noble Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032267 | 2003-09-17 |
| K022206 | 2002-08-29 |
| K010611 | 2001-03-27 |
| K010414 | 2001-03-27 |
| K002826 | 2000-10-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.