FDA UDI
In Commercial Distribution
🇺🇸 United States
Paltop
DI: 07290108694802
·
Model: 60-70137
·
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Paltop
- Primary DI
- 07290108694802
- Version / Model
- 60-70137
- Catalog Number
- 60-70137
- Company Name
- PALTOP ADVANCED DENTAL SOLUTIONS LTD
- Labeler DUNS
- 533836024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-04
- Public Version
- 5
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- 630c1595-4739-4610-bb19-10fb0303e2f0
Device Description
Stepped Depth Pin 3.2/3.8
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
- 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 |
|---|---|---|---|---|
| DZI | Drill, Bone, Powered | Dental | 872.4120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31848 | Periodontal probe, reusable | A hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290108694802 | GS1 |
Customer Contacts
- Phone
- +97246271711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112795 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Stepped Depth Pin 3.2/3.8 |