FDA UDI
In Commercial Distribution
🇺🇸 United States
DentalMark
DI: B971CF231
·
Model: 2.3mm CT ball on denture sized label
·
Jessop Precision Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
110
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Basic Information
- Brand Name
- DentalMark
- Primary DI
- B971CF231
- Version / Model
- 2.3mm CT ball on denture sized label
- Company Name
- Jessop Precision Products Inc.
- Labeler DUNS
- 055127831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 110
- Record Status
- Published
- Publish Date
- 2021-10-08
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 97801765-6154-45cd-a8b2-916dc35126a6
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | Radiology | 892.1640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63530 | Dental guided surgery registration/navigation spatial marker | A non-powered device designed to be attached to the patient’s tooth/teeth to mark the location where a dental procedure (e.g., drilling, implant placement) is to occur during guided dental implantation surgery. It is intended to remain in situ during the preoperative patient registration chairside cone beam computerized tomography (CBCT) scan, and during the dental procedure, to assist with intraoperative navigation (e.g., using optical tracking). Also referred as a navigation fiducial marker, it is made of plastic and radiopaque materials and is attached via dental impression. This is a single-patient device which may be reattached to the patient during the procedure before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B971CF230 | HIBCC | ||||
| Primary | B971CF231 | HIBCC |
Customer Contacts
- Phone
- 800-406-3399
- [email protected]