510(k) K951663
- Device
- TYTIN R
- Applicant
- KERR CORPORATION (DANBURY)
- 510(k) number
- K951663
- Product code
- EJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-06
- Date received
- 1995-04-10
- Regulation
- 872.3070
- Classification name
- Alloy, Amalgam
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFREY A ANDERSON
- Address
- 1332 S. Lone Hill Ave. Glendora CA US 91740 91740
FDA Registration Numbers#
- 3008912871
- 3009496224
- 2020703
- 1316092
- 3012627824
- 3038718579
- 3003794907
- 3010864832
- 2244812
- 2183301
- 3006153346
- 3012187973
- 2515379
- 2648744
- 3012494290
- 8030067
- 3012421607
- 3013557562
- 2024312
- 3004140838
Source Documents#
Other 510(k) Records For Product Code EJJ #
| 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 |
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