FDA UDI
In Commercial Distribution
🇺🇸 United States
PERK Emergency Denture Repair Kit
DI: 00852305002117
·
Model: pk6
·
PERMA LABORATORIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PERK Emergency Denture Repair Kit
- Primary DI
- 00852305002117
- Version / Model
- pk6
- Company Name
- PERMA LABORATORIES LLC
- Labeler DUNS
- 111780698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-14
- Public Version
- 2
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 03dda20b-600e-4d3e-8b17-9f06af2b752d
Device Description
A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBO | Denture Repair Kit | Dental | 872.3570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31787 | Denture repair kit, home-use | A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852305002117 | GS1 |