FDA UDI
In Commercial Distribution
🇺🇸 United States
QuicKlear
DI: EFORC7381301
·
Model: C738-1301
·
Forestadent Bernhard Förster GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QuicKlear
- Primary DI
- EFORC7381301
- Version / Model
- C738-1301
- Catalog Number
- C738-1301
- Company Name
- Forestadent Bernhard Förster GmbH
- Labeler DUNS
- 316074384
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-27
- Public Version
- 4
- Public Version Date
- 2018-10-31
- Public Version Status
- Update
- Public Device Record Key
- 81fd8bb5-6cc6-4177-9235-04544d714fae
Device Description
The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | Dental | 872.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | EFORC7381301 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090933 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | .022 | Inch |