Identity
- Trade Name
- Stratos 300 Grundausstattung FDA UDI
- Generic Name
- Dental articulator FDA UDI
- Device Name
- Stratos 300 Basic Model FDA UDI
- Model / Reference
- 576821BN FDA UDI
- Description
- Stratos 300 Basic Model FDA UDI
Identifiers
- Catalog Number
- 576821BN FDA UDI
- Primary DI / UDI-DI
- DIVO576821BN1 FDA UDI
- FDA Product Code
- EJP FDA UDI
- GMDN Term
- Dental articulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental articulator
Stratos 300 Grundausstattung by Ivoclar Vivadent Aktiengesellschaft — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental articulator.
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- MA2340 W/STRAPS — WHIP-MIX CORP. · Class I
- Hanau Wide-Vue Articulator — WHIP-MIX CORP. · Class I
- 2240 Q Articulator — WHIP-MIX CORP. · 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
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI f8b98cf7-21b6-4391-9045-8fc358b39f23 34 fields · synced Jun 1, 2026