FDA UDI
In Commercial Distribution
🇺🇸 United States
PRO3DURE GR-22 flex
DI: EPRCD1001704
·
Model: 500g - light blue
·
pro3dure medical GmbH
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PRO3DURE GR-22 flex
- Primary DI
- EPRCD1001704
- Version / Model
- 500g - light blue
- Company Name
- pro3dure medical GmbH
- Labeler DUNS
- 312947842
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-14
- Public Version
- 1
- Public Version Date
- 2022-02-22
- Public Version Status
- New
- Public Device Record Key
- 1544fbde-107b-433b-a85a-ffd9ef852c0a
Device Description
printodent GR-22 flex
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MQC | Mouthguard, Prescription | Unknown | U | |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
| KMY | Positioner, Tooth, Preformed | Dental | 872.5525 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16730 | Dental appliance fabrication material, resin | A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EPRCD1001704 | HIBCC |
Customer Contacts
- Phone
- +4923749200500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211415 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 28 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight