Osteon III
510(k) K153676
Osteon III is a Class II device made by GENOSS CO., Ltd., cleared under FDA 510(k) K153676 on 14 Sep 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153676 | Date14 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K153676
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LYC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K153676
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| OsteonIII 3G0205010 | 3G0205010 / 3G0205010 | 08809324768014 | Total Volume 0.1 mL | On the market |
| OsteonIII 3G0205025 | 3G0205025 / 3G0205025 | 08809324768021 | Total Volume 0.25 mL | On the market |
| OsteonIII 3G0205050 | 3G0205050 / 3G0205050 | 08809324768038 | Total Volume 0.5 mL | On the market |
| OsteonIII 3G0205100 | 3G0205100 / 3G0205100 | 08809324768045 | Total Volume 1 mL | On the market |
| OsteonIII 3G0205200 | 3G0205200 / 3G0205200 | 08809324768052 | Total Volume 2 mL | On the market |
| OsteonIII 3G0210010 | 3G0210010 / 3G0210010 | 08809324768069 | Total Volume 0.1 mL | On the market |
| OsteonIII 3G0210025 | 3G0210025 / 3G0210025 | 08809324768076 | Total Volume 0.25 mL | On the market |
| OsteonIII 3G0210050 | 3G0210050 / 3G0210050 | 08809324768083 | Total Volume 0.5 mL | On the market |
| OsteonIII 3G0210100 | 3G0210100 / 3G0210100 | 08809324768090 | Total Volume 1 mL | On the market |
| OsteonIII 3G0210200 | 3G0210200 / 3G0210200 | 08809324768106 | Total Volume 2 mL | On the market |
| OsteonIII 3G0510010 | 3G0510010 / 3G0510010 | 08809324768113 | Total Volume 0.1 mL | On the market |
| OsteonIII 3G0510025 | 3G0510025 / 3G0510025 | 08809324768120 | Total Volume 0.25 mL | On the market |
| OsteonIII 3G0510050 | 3G0510050 / 3G0510050 | 08809324768137 | Total Volume 0.5 mL | On the market |
| OsteonIII 3G0510100 | 3G0510100 / 3G0510100 | 08809324768144 | Total Volume 1 mL | On the market |
| OsteonIII 3G0510200 | 3G0510200 / 3G0510200 | 08809324768151 | Total Volume 2 mL | On the market |
| OsteonIII 3G1020010 | 3G1020010 / 3G1020010 | 08809324768366 | Total Volume 0.1 mL | On the market |
| OsteonIII 3G1020025 | 3G1020025 / 3G1020025 | 08809324768168 | Total Volume 0.25 mL | On the market |
| OsteonIII 3G1020050 | 3G1020050 / 3G1020050 | 08809324768175 | Total Volume 0.5 mL | On the market |
| OsteonIII 3G1020100 | 3G1020100 / 3G1020100 | 08809324768182 | Total Volume 1 mL | On the market |
| OsteonIII 3G1020200 | 3G1020200 / 3G1020200 | 08809324768199 | Total Volume 2 mL | On the market |
| OsteonIII Lifting 3G0205025L | 3G0205025L / 3G0205025L | 08809324768205 | Total Volume 0.25 mL | On the market |
| OsteonIII Lifting 3G0205050L | 3G0205050L / 3G0205050L | 08809324768212 | Total Volume 0.5 mL | On the market |
| OsteonIII Lifting 3G0210025L | 3G0210025L / 3G0210025L | 08809324768229 | Total Volume 0.25 mL | On the market |
| OsteonIII Lifting 3G0210050L | 3G0210050L / 3G0210050L | 08809324768236 | Total Volume 0.5 mL | On the market |
| OsteonIII Lifting 3G0510025L | 3G0510025L / 3G0510025L | 08809324768243 | Total Volume 0.25 mL | On the market |
| OsteonIII Lifting 3G0510050L | 3G0510050L / 3G0510050L | 08809324768250 | Total Volume 0.5 mL | On the market |
| OsteonIII Lifting 3G1020025L | 3G1020025L / 3G1020025L | 08809324768267 | Total Volume 0.25 mL | On the market |
| OsteonIII Lifting 3G1020050L | 3G1020050L / 3G1020050L | 08809324768274 | Total Volume 0.5 mL | On the market |
| OsteonIII Sinus 3G0205025S | 3G0205025S / 3G0205025S | 08809324768281 | Total Volume 0.25 mL | On the market |
| OsteonIII Sinus 3G0205050S | 3G0205050S / 3G0205050S | 08809324768298 | Total Volume 0.5 mL | On the market |
| OsteonIII Sinus 3G0210025S | 3G0210025S / 3G0210025S | 08809324768304 | Total Volume 0.25 mL | On the market |
| OsteonIII Sinus 3G0210050S | 3G0210050S / 3G0210050S | 08809324768311 | Total Volume 0.5 mL | On the market |
| OsteonIII Sinus 3G0510025S | 3G0510025S / 3G0510025S | 08809324768328 | Total Volume 0.25 mL | On the market |
| OsteonIII Sinus 3G0510050S | 3G0510050S / 3G0510050S | 08809324768335 | Total Volume 0.5 mL | On the market |
| OsteonIII Sinus 3G1020025S | 3G1020025S / 3G1020025S | 08809324768342 | Total Volume 0.25 mL | On the market |
| OsteonIII Sinus 3G1020050S | 3G1020050S / 3G1020050S | 08809324768359 | Total Volume 0.5 mL | On the market |
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