← Back to catalogue
Bona-Bite Air (SFS) Chocomint 50ml x 2 - starter pack
EUDAMEDClass I (EU MDR)
Ref 210113111
Identity
- Trade Name
- Bona-Bite Air (SFS) Chocomint 50ml x 2 - starter pack EUDAMED
- Device Name
- Addition Curing Silicone Impression Material EUDAMED
- Model / Reference
- 210113111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05206569002102 EUDAMED
- Basic UDI-DI
- 5206569DSIL22SD EUDAMED
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Silicone dental impression material
Bona-Bite Air (SFS) Chocomint 50ml x 2 - starter pack by DMP Dental Industry S.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Counter-FIT™ Quick 36pk — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class II
- Aquasil Ultra Smart Wetting® Impr Material in digit® Targeted Delivery System — Dentsply International · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5206569DSIL22SD | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DMP Dental Industry S.A.
- EUDAMED SRN
- GR-MF-000019283
Sources (1)
- EUDAMED 0f1973bd-ba36-4cce-b68a-7d1ab7379c82 61 fields · synced Jul 8, 2026