FDA UDI
In Commercial Distribution
🇺🇸 United States
APC™ Flash-Free Clarity™ ADVANCED
DI: 00652221236753
·
Model: 4006-172
·
3M UNITEK CORPORATION
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- APC™ Flash-Free Clarity™ ADVANCED
- Primary DI
- 00652221236753
- Version / Model
- 4006-172
- Catalog Number
- 4006-172
- Company Name
- 3M UNITEK CORPORATION
- Labeler DUNS
- 008256356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 63037ee9-0276-4e85-9898-66a4f3d8d7e8
Device Description
Clarity™ ADVANCED APC™ Flash-Free MBT™ System Upr 5x5 chk, Lwr 5x5 Hk 022
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| NJM | Bracket, ceramic, orthodontic | Dental | 872.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31750 | Orthodontic bracket adhesive | A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused. | No | Active |
| 58937 | Orthodontic bracket, ceramic | A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00652221236753 | GS1 |
Customer Contacts
- Phone
- +1(800)423-4588
- [email protected]