HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12— 510(k) K060363

Name: FDA 510(k) clearance K060363
Creator: U.S. Food and Drug Administration
Published: 2006-07-07

Substantially Equivalent

Hemcon, Inc.

FDA 510(k) clearance K060363 for HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12, Substantially Equivalent on 2006-07-07. Applicant: Hemcon, Inc.. Device class: Unclassified.

Clearance details

Applicant: Hemcon, Inc.
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2006-02-13
Decision date: 2006-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

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K260120 — NaturaJel Oral Wound Care Kit2026-08-05
K251908 — Emanate Tray2026-07-29
K260126 — Curajel Oral Gel2026-06-15
K253816 — MuCover (proposed name) Oral Wound Dressing2026-05-21
K253758 — Dental Cone; Dental Sponge2025-12-18

More clearances from Hemcon, Inc.

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K071519 — HEMCON CHITOFLEX-SURGICAL DRESSING2007-08-06
K043050 — HEMCON BANDAGE AND HEMCON BANDAGE OTC2005-06-03
K030946 — HEMCON BANDAGE OTC; HEMCON CATH/AID2003-06-19
K023298 — HEMCON BANDAGE2002-11-04

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

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.