FDA UDI
In Commercial Distribution
🇺🇸 United States
DENTO PREP
DI: 05713513000164
·
Model: 1900
·
Rønvig Dental Manufacturing A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DENTO PREP
- Primary DI
- 05713513000164
- Version / Model
- 1900
- Company Name
- Rønvig Dental Manufacturing A/S
- Labeler DUNS
- 307549241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-27
- Public Version
- 1
- Public Version Date
- 2022-10-05
- Public Version Status
- New
- Public Device Record Key
- 6ab89c06-e762-49c1-b6cf-2db6efdf643c
Device Description
Dental Micro-blaster for use with aluminium oxide powder.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KOJ | Airbrush | Dental | 872.6080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45403 | Dental abrasive air jet system | An assembly of devices that together comprise a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth or teeth. It typically consists of a control unit, a dedicated handpiece and a foot switch that enables the dentist to control the abrasion process. It has a wide variety of applications such as, the removal of plaque and stains, cleaning fissures (above and below the gingival), the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue and the cleaning of implants prior to loading. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713513000164 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010816 | 000 |