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 |
|---|---|---|---|
| G879102477TIT0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G8791023590 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G8791023580 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G879102335TIT0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G8791023340 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G879102305TIT0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G8791021110 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G8791023020 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G8791023030 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-25 |
| G8791024320 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-23 |
| G8791024330 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-23 |
| G8791024340 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-23 |
| G8791023940 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-10 |
| G879102GS10 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879102GS20 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879102GS30 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879102GS40 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879102GS50 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879102GS60 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879102H1H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879102H2H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879102H3H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| E226016982A11 | KOMET Hand Instruments | Gebr. Brasseler GmbH & Co. KG | 2023-02-01 |
| 04038653034666 | AESCULAP | Aesculap AG | 2020-06-17 |
| 00888118069849 | FILLER | KLS-Martin L.P. | 2018-09-26 |
| 00888118069832 | FILLER | KLS-Martin L.P. | 2018-09-26 |
| 00888118069603 | FILLER | KLS-Martin L.P. | 2018-09-26 |
| 00888118069597 | COMPOSITE INSTRUMENT | KLS-Martin L.P. | 2018-09-26 |
| 00888118069580 | COMPOSITE INSTRUMENT | KLS-Martin L.P. | 2018-09-26 |
| 00888118069573 | COMPOSITE INSTRUMENT | KLS-Martin L.P. | 2018-09-26 |