FDA UDI
In Commercial Distribution
🇺🇸 United States
AeroPro Cordless Prophy System
DI: D691550005200
·
Model: AP-18-PDPC
·
PREMIER DENTAL PRODUCTS COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AeroPro Cordless Prophy System
- Primary DI
- D691550005200
- Version / Model
- AP-18-PDPC
- Catalog Number
- 5500520
- Company Name
- PREMIER DENTAL PRODUCTS COMPANY
- Labeler DUNS
- 014789663
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-10
- Public Version
- 1
- Public Version Date
- 2020-03-18
- Public Version Status
- New
- Public Device Record Key
- 515ec70d-b826-46d3-add4-77818b9df2f3
Device Description
AeroPro Sterilizable Outer Sheath
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63498 | Dental power tool system handpiece, battery-powered | A hand-held, electrically-powered dental device that includes a chuck or collet for attaching a rotary dental endpiece (e.g., polishing brush) intended to be used in dental procedures, typically for cleaning and polishing teeth. It is a battery-powered cordless instrument with an integral electric motor and push buttons for controlling the device settings; the endpiece(s) is not included. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D691550005200 | HIBCC |
Customer Contacts
- Phone
- 610-239-6000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180682 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 45 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal