Identity
- Trade Name
- BioGreen Micro-Applicator - Sample EUDAMEDBioGreen FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- BioGreen EUDAMEDBioGreen Micro-Applicator - Sample FDA UDI
- Model / Reference
- 3005105 EUDAMEDFDA UDI
- Description
- BioGreen Micro-Applicator - Sample FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856402006092 EUDAMEDFDA UDI
- Basic UDI-DI
- 00856402BioGreenT9 EUDAMED
- FDA Product Code
- KXR FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material application tool, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3140 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material application tool, single-use
BioGreen by Premier Dental Products Company — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental material application tool, single-use.
- Ultrabrush — YOUNG MICROBRUSH LLC · Class I
- MAXMICRO — PLASDENT CORP. · Class I
- Accessory — BISCO INC. · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- Sponge Pellets (Small) - Container. — Vista Dental · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- HU-FRIEDY — HU-FRIEDY MFG CO., LLC · Class I
- Benda Brush — CENTRIX, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Premier Dental Products Company
Sources (2)
- FDA UDI 4dabef00-5910-42ef-8549-e9325379299a 33 fields · synced Jun 19, 2026
- EUDAMED 5d1d3b7a-8224-49d7-bb89-13fad766408a 61 fields · synced Jun 19, 2026