FDA UDI
In Commercial Distribution
🇺🇸 United States
SF1LM KO Air Scaler
DI: J021100355111
·
Model: 10035511
·
W & H Dentalwerk Bürmoos GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SF1LM KO Air Scaler
- Primary DI
- J021100355111
- Version / Model
- 10035511
- Company Name
- W & H Dentalwerk Bürmoos GmbH
- Labeler DUNS
- 300238441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-31
- Public Version
- 1
- Public Version Date
- 2018-10-01
- Public Version Status
- New
- Public Device Record Key
- 5d346ada-a11f-4128-a643-5925ed7dc175
Device Description
Brasseler Air Scaler
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
- Yes
- 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 |
|---|---|---|---|---|
| 44911 | Pneumatic dental scaling/debridement system | An assembly of devices designed to use compressed air to generate a vibrating action at its point of patient contact to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. It typically consists of a handpiece which converts pneumatic energy into sonic vibrational energy (e.g., at a frequency of 6 kHz); appropriate connection tubing; and a self-locking, removable tip(s); tip selection typically affects the intended application (endodontic vs periodontal). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | J021100355110 | HIBCC | ||||
| Primary | J021100355111 | HIBCC |