FDA UDI
In Commercial Distribution
🇺🇸 United States
Dandy Scan Body
DI: 05744003810253
·
Model: DE5, Dentsply Sirona - ASTRA TECH EV Ø5.4
·
Coremedtech ApS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dandy Scan Body
- Primary DI
- 05744003810253
- Version / Model
- DE5, Dentsply Sirona - ASTRA TECH EV Ø5.4
- Catalog Number
- 80610199
- Company Name
- Coremedtech ApS
- Labeler DUNS
- 306211589
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-27
- Public Version
- 2
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- ff896c5b-6943-46c1-b591-f85d23c98ff0
- Distribution End Date
- 2100-01-01
Device Description
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61641 | Dental implant abutment analog, scanning | A non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05744003810253 | GS1 |
Customer Contacts
- Phone
- +4522660442
- [email protected]