FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SINCERA
DI: 06974634970029
·
Model: 3ml
·
Sincera Technology (Changchun) Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SINCERA
- Primary DI
- 06974634970029
- Version / Model
- 3ml
- Company Name
- Sincera Technology (Changchun) Co.,Ltd
- Labeler DUNS
- 728113467
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-04
- Public Version
- 1
- Public Version Date
- 2025-06-12
- Public Version Status
- New
- Public Device Record Key
- b7776e79-65d0-4ffc-8c4e-1c62737ae9fd
- Distribution End Date
- 2025-06-04
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63626 | Dental prosthesis-component adhesive | A non-sterile adhesive material (e.g., self- or light-cured polymer composite) intended to be used to bond together components of a restorative dental prosthesis [e.g., crown, removable denture] by functioning as a glue between metal, synthetic, and/or ceramic materials; it is not intended to bond prosthetic devices to patient tissues (e.g., oral mucosa, teeth). Dedicated disposable devices associated with application [e.g., brush, mixing tip] may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974634970029 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241056 | 000 |