KeyPrint KeySplint Soft— 510(k) K183598

Name: FDA 510(k) clearance K183598
Creator: U.S. Food and Drug Administration
Published: 2019-11-15

Substantially Equivalent

Keystone Industries

FDA 510(k) clearance K183598 for KeyPrint KeySplint Soft, Substantially Equivalent on 2019-11-15. Applicant: Keystone Industries. Device class: Unclassified.

Clearance details

Applicant: Keystone Industries
Product code: Code MQC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-12-26
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQC

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K253798 — UltraPrint-Dental Hard Splint UV2026-03-02
K250743 — Remvia NightGuard2025-12-05
K251252 — NOBILCAM IMPAK Disc2025-08-01
K241729 — Hard Splint & Thermo-Adaptive Splint2025-03-18
K243516 — Remi Custom Night Guard2025-02-10

More clearances from Keystone Industries

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K250489 — FP3D2025-05-20
K241089 — KeyPrint KeyDenture Base2024-10-24

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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 →

Recalls naming K183598

K-number listed on FDA's recall record

Z-2336-2021 — KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005Class II·Ongoing·Straumann USA LLC·20210625

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183598.

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