EU Manufacturer
๐บ๐ธ United States
Active
Prime Dental Manufacturing
SRN: US-MF-000008807
ยท
ADDISON STREET 4555, 60641 Chicago, United States
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
10
Watch Prime Dental Manufacturing for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- ADDISON STREET 4555, 60641 Chicago, United States
- [email protected]
- Phone
- +01 773 283 2914
- Website
- PRIMEDENTALMFG.COM
Regulatory Overview
Regulation
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Eu Mdd
5
Classification
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Eu Md Class 2a
4
Eu Md Class 3
1
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | US19/819943531 | SGS Belgium NV | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 10 countries across Europe.
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐น๐ท Tรผrkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| DENTAL CONSERVATION COMPOSITES | EU MDD | Eu Md Class 2a | On Market | 1 |
| Prime-Dent | EU MDD | Eu Md Class 2a | On Market | 1 |
| Prime-Dent Hema Desensitizer | EU MDD | Eu Md Class 3 | On Market | 1 |
| Prime-Dent Light Cure Hybrid Composite | EU MDD | Eu Md Class 2a | On Market | 1 |
| Prime-Dent Light Cure Micro-Hybrid Composite | EU MDD | Eu Md Class 2a | On Market | 1 |