FDA UDI
In Commercial Distribution
🇺🇸 United States
KöR
DI: 00850362007120
·
Model: KöR Retractor & Suction Tip (Ulra)
·
EVOLVE DENTAL TECHNOLOGIES, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KöR
- Primary DI
- 00850362007120
- Version / Model
- KöR Retractor & Suction Tip (Ulra)
- Catalog Number
- 80-1013
- Company Name
- EVOLVE DENTAL TECHNOLOGIES, INC.
- Labeler DUNS
- 005479970
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 1
- Public Version Date
- 2021-04-08
- Public Version Status
- New
- Public Device Record Key
- 004d663f-385c-441a-9f26-213a9b52d663
Device Description
Dental retractor and suction tip.
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
- 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 |
|---|---|---|---|---|
| BRW | Protector, Dental | Anesthesiology | 868.5820 | 1 |
| DYN | Mouthpiece, Saliva Ejector | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63315 | Dental cheek retractor, professional, single-use | A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a single-use device. | No | Active |
| 63670 | Intraoral dental suction tip holder | A non-sterile semi-flexible device intended to be attached to the distal end of a dental suction tip and held between the teeth and cheek of a patient, to allow for hands-free suction during a dental procedure. It is typically a flat disk made of synthetic polymer materials with a clip/loop for attachment to the suction tip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850362007120 | GS1 |