SOCK IT! ORAL PAIN GEL— 510(k) K063148

Name: FDA 510(k) clearance K063148
Creator: U.S. Food and Drug Administration
Published: 2007-01-17

Substantially Equivalent

Merlin Group Dba Mcmerlin Dental Company

FDA 510(k) clearance K063148 for SOCK IT! ORAL PAIN GEL, Substantially Equivalent on 2007-01-17. Applicant: Merlin Group Dba Mcmerlin Dental Company. Device class: Unclassified.

Clearance details

Applicant: Merlin Group Dba Mcmerlin Dental Company
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2006-10-16
Decision date: 2007-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Prairie, TX, 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

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.