FDA UDI
In Commercial Distribution
🇺🇸 United States
s-Clean MU Straight Abutment Guide
DI: 08800053022323
·
Model: DSMUSG
·
DENTIS CO. ,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- s-Clean MU Straight Abutment Guide
- Primary DI
- 08800053022323
- Version / Model
- DSMUSG
- Company Name
- DENTIS CO. ,LTD
- Labeler DUNS
- 694721181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-31
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 87d6c462-8b34-442c-9de5-9cfd93ee6bd9
Device Description
Dental Implant Instrument / s-Clean MU Straight Abutment Guide
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 08800053022323 | GS1 |