Identity
- Trade Name
- MixStar eMotion FDA UDI
- Generic Name
- Dental impression material mixer FDA UDI
- Device Name
- MixStar eMotion. Fully automatic mixing device for impression materials. High-Speed Design. FDA UDI
- Model / Reference
- 999482 FDA UDI
- Description
- MixStar eMotion. Fully automatic mixing device for impression materials. High-Speed Design. FDA UDI
Identifiers
- Catalog Number
- 999482 FDA UDI
- Primary DI / UDI-DI
- EDMG9994821 FDA UDI
- FDA Product Code
- EFD FDA UDI
- GMDN Term
- Dental impression material mixer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression material mixer
MixStar eMotion by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression material mixer.
- Dynamix Speed 2 — Renfert GmbH · Class I
- 3M™ Imprint™ — 3M Deutschland GmbH · Class I
- VOCO Dynamic Dispenser — VOCO GmbH · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Imprint™ 4 Penta™ Super Quick Heavy — 3M Deutschland GmbH · Class I
- Dynamix Speed 2 US — Kulzer, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DMG Chemisch-Pharmazeutische Fabrik GmbH
Sources (1)
- FDA UDI cb6568bf-eaed-4b8b-8ef5-b83681082ee1 35 fields · synced May 30, 2026