Product code EJJ
- Device name
- Alloy, 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053114 | SILVERFIL | Dunia Perwira Manufacturing Sdn. Bhd. | 2005-11-15 |
| K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 | Septodont | 2005-05-02 |
| K033434 | BESTALOY | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| K032152 | BENCO ADMIX | Southern Dental Industries, Inc. | 2003-08-06 |
| K031658 | BENCO SPHERICAL | Southern Dental Industries, Inc. | 2003-07-29 |
| K020452 | HIGH SILVER CONVENTIONAL | Ab Ardent | 2002-05-07 |
| K011801 | FUTURA TOPCAP NON GAMMA-2 | Ab Ardent | 2001-08-16 |
| K002810 | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 |
| K002808 | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 |
| K002811 | ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 |
| K991481 | PARAGON | Lancer Orthodontics, Inc. | 1999-08-11 |
| K982671 | SECURALLOY | Specialites Septodont | 1998-10-19 |
| K982460 | VIVACAP HR | Ab Ardent | 1998-08-24 |
| K982458 | VIVALLOY HR | Ab Ardent | 1998-08-24 |
| K982456 | AMALCAP PLUS | Ab Ardent | 1998-08-24 |
| K974035 | CENTURY ALLOY | Dentsply Intl. | 1997-12-17 |
| K973086 | PLA-96P | Southern Dental Industries, Inc. | 1997-10-07 |
| K973088 | PLS-96P | Southern Dental Industries, Inc. | 1997-10-03 |
| K964192 | ARDENT NON GAMMA-2 70 | Ardent Production Development | 1997-01-06 |
| K964775 | ARDENT FUTURA NON GAMMA-2 | Ardent Production Development | 1996-12-10 |
| K955285 | GALLOY | Southern Dental Industries, Inc. | 1996-01-24 |
| K952670 | CUPRALLOY | Wykle Research, Inc. | 1995-08-25 |
| K951663 | TYTIN R | Kerr Corporation (Danbury) | 1995-06-06 |
| K951865 | ULTRA SPHERICAL AMALGAM ALLOY | Goldsmith & Revere, Inc. | 1995-05-25 |
| K951511 | TYTIN ADMIX | Kerr Corporation (Danbury) | 1995-05-02 |
| K942430 | AGALLOY, DISALLOY, EPSILON AND LAMBDA | Fen Dental Mfg., Inc. | 1994-07-14 |
| K940675 | SYBRALOY | Sybron Dental Specialties, Inc. | 1994-04-29 |
| K935535 | TYTIN | Kerr Corporation (Danbury) | 1994-03-11 |
| K936113 | INDIPERSE | Indisperse Distributing, Inc. | 1994-02-10 |
| K933309 | PRINCE | Goldsmith & Revere, Inc. | 1993-10-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810063752528 | Safco Conform T-Type Spherical Amalgam | SAFCO DENTAL SUPPLY CO. | 2022-12-12 |
| 10810063752511 | Safco Conform T-Type Spherical Amalgam | SAFCO DENTAL SUPPLY CO. | 2022-12-12 |
| 10810063752504 | Safco Conform T-Type Spherical Amalgam | SAFCO DENTAL SUPPLY CO. | 2022-12-12 |
| 10810063752498 | Safco Conform T-Type Spherical Amalgam | SAFCO DENTAL SUPPLY CO. | 2022-12-12 |
| 10810063752481 | Safco Conform T-Type Spherical Amalgam | SAFCO DENTAL SUPPLY CO. | 2022-12-12 |
| 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 |
| 07701126651031 | Nu Alloy Dp Active Caps. Jar X 50 - 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 |
| 07701126650980 | Nu Alloy dp Caps. Jar X 500 - 2 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 |
| 07701126650966 | Nu Alloy dp Active Caps. Jar X 500 - 1 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 |
| D00265628221 | Dispersalloy® Dispersed Phase Alloy | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D00265628211 | Dispersalloy® Dispersed Phase Alloy | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026562631 | Dispersalloy® Dispersed Phase Alloy | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026562621 | Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026562611 | Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026030161 | Megalloy®EZ Spherical Amalgam | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026030151 | Megalloy®EZ Spherical Amalgam | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026030141 | Megalloy®EZ Spherical Amalgam | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026030061 | Megalloy®EZ Spherical Amalgam | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026030051 | Megalloy®EZ Spherical Amalgam | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| D0026030041 | Megalloy®EZ Spherical Amalgam | DENTSPLY INTERNATIONAL INC. | 2016-09-21 |
| 10841396117845 | Tytin FC | KERR CORPORATION | 2016-08-31 |
| 10841396117784 | Tytin FC | KERR CORPORATION | 2016-08-31 |
| 10841396117777 | Tytin FC | KERR CORPORATION | 2016-08-31 |
| 10841396117760 | Tytin FC | KERR CORPORATION | 2016-08-31 |