GBR system
by Surgident
510(k) K170697
GBR system is a Class II device made by Surgident, cleared under FDA 510(k) K170697 on 24 May 2018, active as of 11 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 | NumberK170697 | Date24 May 2018 | StatusActive |
Official records
- FDA 510(k) database K170697
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JEY
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K170697
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 | |||
|---|---|---|---|---|
| GBR System SDB-140-035 | SDB-140-035 | 08800041000005 | — | On the market |
| GBR System SDB-140-050 | SDB-140-050 | 08800041000012 | — | On the market |
| GBR System SDP-S22-015 | SDP-S22-015 | 08800041000203 | — | On the market |
| GBR System SDP-S36-022 | SDP-S36-022 | 08800041000210 | — | On the market |
| GBR System SDP-S44-044 | SDP-S44-044 | 08800041000227 | — | On the market |
| GBR System SDP-T22-015 | SDP-T22-015 | 08800041000234 | — | On the market |
| GBR System SDP-T36-022 | SDP-T36-022 | 08800041000241 | — | On the market |
| GBR System SDP-T44-044 | SDP-T44-044 | 08800041000258 | — | On the market |
| GBR System SDS-140-030 | SDS-140-030 | 08800041000029 | — | On the market |
| GBR System SDS-140-040 | SDS-140-040 | 08800041000036 | — | On the market |
| GBR System SDS-140-060 | SDS-140-060 | 08800041000043 | — | On the market |
| GBR System SDS-140-080 | SDS-140-080 | 08800041000050 | — | On the market |
| GBR System SDS-140-100 | SDS-140-100 | 08800041000067 | — | On the market |
| GBR System SDS-140-120 | SDS-140-120 | 08800041000074 | — | On the market |
| GBR System SDS-160-030 | SDS-160-030 | 08800041000081 | — | On the market |
| GBR System SDS-160-040 | SDS-160-040 | 08800041000098 | — | On the market |
| GBR System SDS-160-060 | SDS-160-060 | 08800041000104 | — | On the market |
| GBR System SDS-160-080 | SDS-160-080 | 08800041000111 | — | On the market |
| GBR System SDS-160-100 | SDS-160-100 | 08800041000128 | — | On the market |
| GBR System SDS-160-120 | SDS-160-120 | 08800041000135 | — | On the market |
| GBR System SDS-200-030 | SDS-200-030 | 08800041000142 | — | On the market |
| GBR System SDS-200-040 | SDS-200-040 | 08800041000159 | — | On the market |
| GBR System SDS-200-060 | SDS-200-060 | 08800041000166 | — | On the market |
| GBR System SDS-200-080 | SDS-200-080 | 08800041000173 | — | On the market |
| GBR System SDS-200-100 | SDS-200-100 | 08800041000180 | — | On the market |
| GBR System SDS-200-120 | SDS-200-120 | 08800041000197 | — | On the market |
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