FDA UDI
In Commercial Distribution
🇺🇸 United States
DIAGNOdent Paro Tip Saphir without scale
DI: EKAV100403700
·
Model: 1.004.0370
·
KaVo Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DIAGNOdent Paro Tip Saphir without scale
- Primary DI
- EKAV100403700
- Version / Model
- 1.004.0370
- Catalog Number
- NA
- Company Name
- KaVo Dental GmbH
- Labeler DUNS
- 333710619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 4
- Public Version Date
- 2021-11-08
- Public Version Status
- Update
- Public Device Record Key
- b0a01373-3e16-4b6b-91c5-8cc6a45774d4
Device Description
This is a medical device.This is a medical device.
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
- No
- 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 |
|---|---|---|---|---|
| NTK | Caries detector, laser light, transmission | Dental | 872.1745 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33995 | Dental caries detector, optical induced fluorescence | A mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EKAV100403700 | HIBCC |
Customer Contacts
- Phone
- +18475506800
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 80 Degrees Celsius