PiezoImplant System— 510(k) K211872

Substantially Equivalent

Rex Implants, Inc.

FDA 510(k) clearance K211872 for PiezoImplant System, Substantially Equivalent on 2022-10-12. Applicant: Rex Implants, Inc.. Device class: 2.

Clearance details

Applicant: Rex Implants, Inc.
Product code: Code NRQ
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2021-06-17
Decision date: 2022-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NRQ

K981954 — VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS1999-01-25
K822969 — GENERATION 5 LINKOW BLADE IMPLANTS1982-11-04
K791366 — ORATRONICS ENDOSSEOUS FRAME ASSEMBLY1979-10-09
K791204 — MITER ENDOSTEAL BLADE IMPLANT1979-09-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.