510(k) Report

FDA applicant

Merlin Group Dba Mcmerlin Dental Company

Grand Prairie, TX1 decision2007–20070 recalls

FDA records 1 decision for Merlin Group Dba Mcmerlin Dental Company (Grand Prairie, TX) in 2007: 1 510(k) clearance. All are in product code OLR (Oral Wound Dressing). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Merlin Group Dba Mcmerlin Dental Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Merlin Group Dba Mcmerlin Dental Company by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLROral Wound Dressing1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063148Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 20074cite it

What has FDA decided for it lately?

  • K063148Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007

The one decision as Merlin Group Dba Mcmerlin Dental Company →

Other applicant names beginning “Merlin”

FDA records each applicant name separately; these may or may not be the same firm.

Merlin Engineering Works, Inc. 8Merlin Medical Limited 2The Merlin Corp. 2