1ST IMPRESSION— 510(k) K921571

Substantially Equivalent

Wykle Research, Inc.

FDA 510(k) clearance K921571 for 1ST IMPRESSION, Substantially Equivalent on 1993-09-10. Applicant: Wykle Research, Inc.. Device class: 2.

Clearance details

Applicant: Wykle Research, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1992-04-02
Decision date: 1993-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carson City, NV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

K254142 — Dia-X Sil Heavy Body2026-09-16
K254152 — Dia-X Sil Light Body2026-09-16
K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27

More clearances from Wykle Research, Inc.

K952670 — CUPRALLOY1995-08-25
K910632 — ACCU-MIX AMALGAMATOR1991-03-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.