E-Guard— 510(k) K201173

Clearance details

Applicant

Envisiontec GmbH

Product code

Code MQC

Device class

Unclassified

Advisory panel

Unknown

Date received

2020-05-01

Decision date

2020-11-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gladbeck, DE

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• K241729 — Hard Splint & Thermo-Adaptive Splint2025-03-18
• K243516 — Remi Custom Night Guard2025-02-10

• K220894 — SmileGuard2022-06-10
• K211101 — E-Temp2021-06-14
• K210977 — E-Dent 10002021-05-25
• K203641 — E-Denture Pro2021-03-30

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 →

• Z-0746-2022 — PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.Class II·Ongoing·Envisiontec US Llc·20220120

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201173.