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Envisiontec GmbH

Germany·DE-MF-000009311

Last updated September 17, 2026

Information

Country: Germany
Address: 51, Brüsseler Strasse, Gladbeck, Germany
Website: www.envisiontec.de
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49 2043 9875 0
PRRC Contact: Rüdiger van Bernum
EUDAMED SRN: DE-MF-000009311
FDA FEI Number: 3012389497
DUNS Number: 332025159

Catalogue (76)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Flexcera Smile Bleach	RES-01-3139	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ A3.5	RES-01-3149	FDA UDI	Class II	Active
Flexcera Base Ultra+ Dark Meharry	RES-01-3504	FDA UDI	Class II	Active
SmileGuard	RES-01-3194	FDA UDI	Class I	Active
Flexcera Smile A1	RES-01-3134	FDA UDI	Class II	Active
E-Tray	RES-01-3114	FDA UDI	Class I	Active
Flexcera™ Smile Ultra+ for Carbon® Printers Bleach	RES-01-3351	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ A3.5 0.5kg	RES-01-3185	FDA UDI	Class II	Active
E-Guide	RES-01-3012	FDA UDI	Class I	Active
Flexcera Base Original Pink	RES-01-3140	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ B1 0.5kg	RES-01-3186	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ Bleach	RES-01-3151	FDA UDI	Class II	Active
E-Guard Blue	RES-01-3121	FDA UDI	U	Active
Flexcera™ Smile Ultra+ A3	RES-01-3148	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ A2 0.5kg	RES-01-3183	FDA UDI	Class II	Active
Flexcera Smile A3.5	RES-01-3137	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ A1 0.5kg	RES-01-3182	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ Bleach 0.5kg	RES-01-3187	FDA UDI	Class II	Active
Flexcera™ Base Ultra+ Medium Pink	RES-01-3501	FDA UDI	Class II	Active
Flexcera Smile A2	RES-01-3135	FDA UDI	Class II	Active
Flexcera Base Dark Meharry	RES-01-3144	FDA UDI	Class II	Active
Flexcera Base Ultra+ Pink	RES-01-3500	FDA UDI	Class II	Active
Flexcera Smile A3	RES-01-3136	FDA UDI	Class II	Active
Flexcera Base Ultra+ Light Pink	RES-01-3503	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ A2	RES-01-3147	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ for Carbon® Printers B1	RES-01-3350	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ B1	RES-01-3150	FDA UDI	Class II	Active
E-Guide Soft	RES-01-3115	FDA UDI	Class I	Active
Flexcera™ Smile Ultra+ A1	RES-01-3146	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ for Carbon® Printers A1	RES-01-3346	FDA UDI	Class II	Active
Flexcera Base Light Pink	RES-01-3143	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ for Carbon® Printers A2	RES-01-3347	FDA UDI	Class II	Active
E-Guard	RES-01-3113	FDA UDI	U	Active
Flexcera Base Dark Pink	RES-01-3142	FDA UDI	Class II	Active
Flexcera Smile B1	RES-01-3138	FDA UDI	Class II	Active
Flexcera Base Medium Pink	RES-01-3141	FDA UDI	Class II	Active
Flexcera™ Base Ultra+ Dark Pink	RES-01-3502	FDA UDI	Class II	Active
Flexcera™ Smile Ultra+ A3 0.5kg	RES-01-3184	FDA UDI	Class II	Active
SmileGuard	K220894	FDA 510(k)	U	Active
Flexcera Base Ultra+ Pink	RES-01-3600	EUDAMED	Class I	Active
Flexcera Base Dark Pink	RES-01-3242	EUDAMED	Class I	Active
Flexcera Base Ultra+ Light Pink	RES-01-3603	EUDAMED	Class I	Active
E-Temp	K211101	FDA 510(k)	Class II	Active
E-Denture Pro	K203641	FDA 510(k)	Class II	Active
E-Dent 1000	K210977	FDA 510(k)	Class II	Active
E-Tray	RES-01-3214	EUDAMED	Class I	Active
Flexcera Smile A2	RES-01-3235	EUDAMED	Class I	Active
Flexcera Smile A3	RES-01-3236	EUDAMED	Class I	Active
Flexcera Base Ultra+ Medium Pink	RES-01-3601	EUDAMED	Class I	Active
Flexcera Smile Ultra+ A3 0.5kg	RES-01-3284	EUDAMED	Class IIa	Active

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