Product code EIY
- Device name
- Instrument, Filling, Plastic, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871909 | COMPOSITE RESTORATIVE CARRIER | Dentsply Intl. | 1987-05-27 |
| K851726 | 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN | Artiberia | 1985-07-02 |
| K833955 | NOVEL DISPENSER/PACKAGE | Dentsply Intl. | 1984-01-03 |
| K830776 | MICROFIL CONTOURING INSTRUMENTS | Almore Intl., Inc. | 1983-04-28 |
| K823323 | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | Miltex, Inc. | 1982-11-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| ESAM2029001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2053001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2052001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2051001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2047001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2046001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2045001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2044001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2043001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2042001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2041001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2035001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2034001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2033001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2030001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12011101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2028001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2005001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2004001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2003001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2002001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM2001001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13312301 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13312001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12014111 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12014101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12013111 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12013101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12012101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12011111 | STOMA® | Storz am Mark GmbH | 2020-08-27 |