510(k) K211872
- Device
- PiezoImplant System
- Applicant
- Rex Implants, Inc.
- 510(k) number
- K211872
- Product code
- NRQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-12
- Date received
- 2021-06-17
- Regulation
- 872.3640
- Classification name
- Blade-form Endosseous Dental Implant
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Giuseppe Vercellotti
- Address
- 850 Michigan Ave. Columbus OH US 43215 43215
FDA Registration Numbers#
- 3014174860
- 3008870565
Source Documents#
Other 510(k) Records For Product Code NRQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981954 | VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS | Healthline Implants, Inc. | 1999-01-25 |
| K822969 | GENERATION 5 LINKOW BLADE IMPLANTS | Leonard P. Linkow, D.D.L. | 1982-11-04 |
| K791366 | ORATRONICS ENDOSSEOUS FRAME ASSEMBLY | Oratronics, Inc. | 1979-10-09 |
| K791204 | MITER ENDOSTEAL BLADE IMPLANT | Depuy, Inc. | 1979-09-28 |
Legacy Summary#
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FDA Review#
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