INTERGRO ORAL— 510(k) K070147

Substantially Equivalent

Biomet 3i

FDA 510(k) clearance K070147 for INTERGRO ORAL, Substantially Equivalent on 2007-05-14. Applicant: Biomet 3i. Device class: 2.

Clearance details

Applicant: Biomet 3i
Product code: Code NUN
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2007-01-16
Decision date: 2007-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUN

K130235 — SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY2014-01-10
K113645 — REGENEROSS ALLOGRAFT PLUS MINERLIZED2012-01-20
K103699 — EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC2011-08-12
K091217 — DBX DEMINERALIZED BONE MATRIX PUTTY2009-10-02
K082463 — PROGENIX2008-11-10

More clearances from Biomet 3i

K183138 — Certain BellaTek Express and BellaTek Flex Abutments2019-07-02
K173374 — TSV BellaTek Encode Healing Abutments2017-12-13
K170013 — Eztetic BellaTek Encode Healing Abutments2017-09-21
K150571 — 3i T3 Short Implants2015-11-20
K133049 — 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS2014-01-08

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