Product code OIV
- Device name
- Dental Amalgam
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3070
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223182 | Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy | Worldwork S.R.L | 2023-05-01 |
| K140125 | NEW STETIC DENTAL AMALGAM ALLOY | New Stetic | 2014-04-29 |
| K081273 | ULTRACAPS S | Sdi , Ltd. | 2008-07-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07701126651000 | Nu Alloy Caps. Jar X 50 - 2 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-24 |
| 07701126651024 | Nu Alloy Active Caps. Jar X 50 - 1 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-24 |
| 07701126651048 | Nu Alloy Dp Active Caps. Jar X 50 - 3 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-24 |
| 07701126650959 | Nu Alloy dp Active Caps. Jar X 500 - 2 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-23 |
| 07701126650966 | Nu Alloy dp Active Caps. Jar X 500 - 1 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-23 |
| 07701126650973 | Nu Alloy Caps. Jar X 500 - 1 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-23 |
| 07701126650980 | Nu Alloy dp Caps. Jar X 500 - 2 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-23 |
| 07701126650997 | Nu Alloy Caps. Jar X 50 - 1 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-23 |
| 07701126651031 | Nu Alloy Dp Active Caps. Jar X 50 - 2 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-05-23 |
| 07701126650898 | Nu Alloy dp40 Caps. Jar X 500 - 1 Spill | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | 2017-02-01 |
| 00853383006257 | Original D Tablets Regular Set 5 oz | Wykle Research, Inc | 2016-09-23 |
| 00853383006240 | Original D Capsules 3 Spill Fast Set 500 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006233 | Original D Capsules 3 Spill Fast Set 100 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006226 | Original D Capsules 3 Spill Fast Set 50 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006219 | Original D Capsules 2 Spill Fast Set 50 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006202 | Original D Capsules 2 Spill Fast Set 100 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006196 | Original D Capsules 2 Spill Extra Fast Set 500 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006189 | Original D Capsules 1 Spill Fast Set 500 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006172 | Original D Capsules 1 Spill Fast Set 100 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006165 | Original D Powder Fast Set 10 oz | Wykle Research, Inc | 2016-09-23 |
| 00853383006158 | Original D Tablets Fast Set 10 oz | Wykle Research, Inc | 2016-09-23 |
| 00853383006141 | Original D Tablets Fast Set 5 oz | Wykle Research, Inc | 2016-09-23 |
| 00853383006134 | Original D Capsules 2 Spill Extra Fast Set 500 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006127 | Original D Capsules 2 Spill Extra Fast Set 100 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006110 | Original D Capsules 2 Spill Extra Fast Set 50 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006103 | Original D Capsules 1 Spill Extra Fast 500 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006097 | Original D Capsules 1 Spill Extra Fast Set 100 caps | Wykle Research, Inc | 2016-09-23 |
| 00853383006028 | Original D Capsules 1 Spill Extra Fast Set 50 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006011 | Original D Capsules 1 Spill Fast Set 50 count | Wykle Research, Inc | 2016-09-23 |
| 00853383006004 | Original D Capsules 1 Spill Regular Set 50 count | Wykle Research, Inc | 2016-09-23 |