FDA UDI
In Commercial Distribution
🇺🇸 United States
PEEK BioSolution
DI: D7091018986
·
Model: PEEK BioSolution A2/B2 diameter 100mm, thickness 26mm
·
Merz Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PEEK BioSolution
- Primary DI
- D7091018986
- Version / Model
- PEEK BioSolution A2/B2 diameter 100mm, thickness 26mm
- Catalog Number
- 1018986
- Company Name
- Merz Dental GmbH
- Labeler DUNS
- 324914910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8a834ff4-fb00-490b-8602-a10158961353
Device Description
PEEK BioSolution A2/B2 diameter 100mm, thickness 26mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61718 | Preformed dental crown, permanent | A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure (e.g. disposable prosthesis gauge). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7091018986 | HIBCC |
Customer Contacts
- Phone
- +494381403411
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 100 | Millimeter | |
| Height | 26 | Millimeter |