Benda Wedge
510(k) K140144
Benda Wedge is a medical device (FDA Class I; FDA product code EJB, Handle, Instrument, Dental) made by Centrix, Inc., cleared under FDA 510(k) K140144 on 8 Jul 2014, 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 | NumberK140144 | Date8 Jul 2014 | StatusActive |
Official records
- FDA 510(k) database K140144
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EJB
- Device class
- Class I
- Regulation
- 21 CFR Part 872.4565
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K140144
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 | |||
|---|---|---|---|---|
| A+Wedge® GWABL | GWABL / GWABL | 10810038092970 | — | On the market |
| A+Wedge® GWAGR | GWAGR / GWAGR | 10810038092994 | — | On the market |
| A+Wedge® GWAK4 | GWAK4 / GWAK4 | 00810038095684 | — | On the market |
| A+Wedge® GWAOR | GWAOR / GWAOR | 10810038092987 | — | On the market |
| A+Wedge® GWAS01 | GWAS01 / GWAS01 | 00810038095691 | — | On the market |
| A+Wedge® GWAS02 | GWAS02 / GWAS02 | 00810038095707 | — | On the market |
| A+Wedge® GWAYL | GWAYL / GWAYL | 10810038092963 | — | On the market |
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Other devices filed under FDA product code EJB (Handle, Instrument, Dental).
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- ESTHETIC PLUS 0005030009 by TDV DENTAL LTDA