FDA UDI
In Commercial Distribution
🇺🇸 United States
CORiTEC PMMA transpa Disc
DI: D70952500598220
·
Model: CORiTEC PMMA transpa Disc thickness 20mm, diameter 98,5mm, clear, with notch
·
Merz Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CORiTEC PMMA transpa Disc
- Primary DI
- D70952500598220
- Version / Model
- CORiTEC PMMA transpa Disc thickness 20mm, diameter 98,5mm, clear, with notch
- Catalog Number
- 52500598220
- Company Name
- Merz Dental GmbH
- Labeler DUNS
- 324914910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 878dcbbd-d59d-4f99-9d6c-eed88a82b00e
Device Description
CORiTEC PMMA transpa Disc thickness 20mm, diameter 98,5mm, clear, with notch
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 |
|---|---|---|---|---|
| MQC | Mouthguard, Prescription | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43025 | Dental occlusal splint, custom-made | A rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D70952500598220 | HIBCC |
Customer Contacts
- Phone
- +494381403411
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K134015 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 20 | Millimeter | |
| Outer Diameter | 98.5 | Millimeter |