FDA UDI
In Commercial Distribution
🇺🇸 United States
Medidenta Air Free 90 Titan
DI: D884AFT900
·
Model: AFT90
·
Flight Dental Systems
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Medidenta Air Free 90 Titan
- Primary DI
- D884AFT900
- Version / Model
- AFT90
- Company Name
- Flight Dental Systems
- Labeler DUNS
- 241275150
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-10
- Public Version
- 1
- Public Version Date
- 2021-02-18
- Public Version Status
- New
- Public Device Record Key
- 7abbd420-5257-4437-a1f2-1cad843cf86b
Device Description
The Air-Free does not allow any air to vent out of the head of the handpiece. This will eliminate air sensitivity and patient discomfort during removal of bonding adhesive (i.e. Invisalign attachments); providing your patients with a pain and stress free appointment
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40958 | Dental power tool system handpiece, pneumatic | A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D884AFT900 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181691 | 000 |