NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE— 510(k) K933150

Name: FDA 510(k) clearance K933150
Creator: U.S. Food and Drug Administration
Published: 1993-10-20

Substantially Equivalent

Nobelpharma USA, Inc.

FDA 510(k) clearance K933150 for NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE, Substantially Equivalent on 1993-10-20. Applicant: Nobelpharma USA, Inc.. Device class: 2.

Clearance details

Applicant: Nobelpharma USA, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1993-06-29
Decision date: 1993-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE1999-06-28
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K955713 — NOBELPHARMA BONE ANCHORED HEARING AID1996-08-09
K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE1996-07-22
K961736 — 17 ANGULATED ABUTMENT1996-07-18

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.