BONE GRAFT SCREW SYSTEM— 510(k) K973056

Name: FDA 510(k) clearance K973056
Creator: U.S. Food and Drug Administration
Published: 1997-11-12

Substantially Equivalent

Bicon, Inc.

FDA 510(k) clearance K973056 for BONE GRAFT SCREW SYSTEM, Substantially Equivalent on 1997-11-12. Applicant: Bicon, Inc.. Device class: 2.

Clearance details

Applicant: Bicon, Inc.
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 1997-08-15
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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K233419 — GBR System2025-01-03

More clearances from Bicon, Inc.

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K062044 — THE 5.0 X 6.0MM DENTAL IMPLANT2006-11-21
K051091 — SYNTHOGRAFT2005-09-01
K050712 — 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT2005-04-22
K050408 — BICON ORTHODONTIC IMPLANT SYSTEM2005-04-07
K031568 — BICONITE SURFACE TREATMENT2004-11-23

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.