FDA UDI
In Commercial Distribution
🇺🇸 United States
Ceramill Splintec
DI: D709760319
·
Model: Ceramill Splintec 71 L US 20mm
·
Merz Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ceramill Splintec
- Primary DI
- D709760319
- Version / Model
- Ceramill Splintec 71 L US 20mm
- Catalog Number
- 760319
- Company Name
- Merz Dental GmbH
- Labeler DUNS
- 324914910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2025-01-27
- Public Version Status
- Update
- Public Device Record Key
- 2ee70898-05f5-4254-8f89-8b9adb80c281
Device Description
Ceramill Splintec 71 L US 20mm
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 | 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 | D709760319 | 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 | 71 | Millimeter |