SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM— 510(k) K062749

Name: FDA 510(k) clearance K062749
Creator: U.S. Food and Drug Administration
Published: 2006-11-29

Substantially Equivalent

Nobel Biocare AB

FDA 510(k) clearance K062749 for SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM, Substantially Equivalent on 2006-11-29. Applicant: Nobel Biocare AB. Device class: 2.

Clearance details

Applicant: Nobel Biocare AB
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2006-09-14
Decision date: 2006-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goteborg, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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