FDA UDI
In Commercial Distribution
🇺🇸 United States
ZE-55 RM Scaler
DI: J021110155011
·
Model: 11015501
·
W & H Dentalwerk Bürmoos GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ZE-55 RM Scaler
- Primary DI
- J021110155011
- Version / Model
- 11015501
- 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
- 2019-09-10
- Public Version
- 1
- Public Version Date
- 2019-09-18
- Public Version Status
- New
- Public Device Record Key
- fe7ce8fe-2f20-4f26-bff3-9176e9da974b
Device Description
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 |
|---|---|---|---|---|
| 44909 | Pneumatic dental scaling/debridement system handpiece | A holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip 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. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | J021110155010 | HIBCC | ||||
| Primary | J021110155011 | HIBCC |