FDA UDI
In Commercial Distribution
🇺🇸 United States
Primeprint Guide
DI: EDET027101
·
Model: 02710
·
DETAX GmbH
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Primeprint Guide
- Primary DI
- EDET027101
- Version / Model
- 02710
- Company Name
- DETAX GmbH
- Labeler DUNS
- 343947949
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-12
- Public Version
- 4
- Public Version Date
- 2024-10-21
- Public Version Status
- Update
- Public Device Record Key
- 2ea7401f-292b-4f12-b0a9-0489e5a05c95
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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMY | Positioner, Tooth, Preformed | Dental | 872.5525 | 1 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
| DYJ | Retainer, Screw Expansion, Orthodontic | Dental | 872.5410 | 1 |
| DYT | Maintainer, Space Preformed, Orthodontic | Dental | 872.5525 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43025 | Removable dental occlusal splint, custom-made | A rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth 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). It is removable by the patient (e.g., during meals), and is typically made of synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EDET027101 | HIBCC |