FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Paltop
DI: 07290108699463
·
Model: 40-70289
·
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Paltop
- Primary DI
- 07290108699463
- Version / Model
- 40-70289
- Catalog Number
- 40-70289
- Company Name
- PALTOP ADVANCED DENTAL SOLUTIONS LTD
- Labeler DUNS
- 533836024
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-02
- Public Version
- 4
- Public Version Date
- 2024-11-19
- Public Version Status
- Update
- Public Device Record Key
- 89c2cc17-42c9-4659-9d64-23ca58ec8735
- Distribution End Date
- 2024-10-31
Device Description
Paltop Equator Protective Disc Pink
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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
- High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, implant, dental, endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38603 | Resilient dental precision attachment | A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290108699463 | GS1 |
Customer Contacts
- Phone
- +97246271711
- [email protected]