FDA UDI
In Commercial Distribution
🇺🇸 United States
Flight Dental Systems
DI: D178A12HP1000
·
Model: A12H-100
·
Flight Dental Systems USA Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flight Dental Systems
- Primary DI
- D178A12HP1000
- Version / Model
- A12H-100
- Catalog Number
- A12 Operatory Package
- Company Name
- Flight Dental Systems USA Inc.
- Labeler DUNS
- 119439759
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-29
- Public Version
- 1
- Public Version Date
- 2025-09-08
- Public Version Status
- New
- Public Device Record Key
- 2a876a19-f71d-41e0-8dc7-14c977448977
Device Description
The A12 Operatory Package is a hydraulic dental chair with a radius swing mount delivery system. The dental chair features an ergonomic back and seat with synchronized movement. The chair also has the ability to rotate 30 degrees to the left and right
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62725 | Dental delivery system instrument unit, pneumatic | A pneumatically-powered device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D178A12HP1000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070196 | 000 |