FDA UDI
In Commercial Distribution
🇺🇸 United States
Palodent® 360
DI: D0026596011
·
Model: 659601
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
48
Basic Information
- Brand Name
- Palodent® 360
- Primary DI
- D0026596011
- Version / Model
- 659601
- Catalog Number
- 659601
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 48
- Record Status
- Published
- Publish Date
- 2022-08-16
- Public Version
- 1
- Public Version Date
- 2022-08-24
- Public Version Status
- New
- Public Device Record Key
- 1963a0f7-80bb-4b7a-ad79-c866d18ae226
Device Description
Palodent® 360 Matrice Refill - Size 4.5mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | INSTRUMENTS, DENTAL HAND | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38786 | Dental matrix band, single-use | A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D0026596010 | HIBCC | ||||
| Primary | D0026596011 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 48 Matrices, Size 4.5mm (Dark Blue) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from moisture or excessive humidity.