FDA UDI
In Commercial Distribution
🇺🇸 United States
Roetzer Posterior Packer Sculptor (PPS) Instrument
DI: 00723896008782
·
Model: 7129540
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Roetzer Posterior Packer Sculptor (PPS) Instrument
- Primary DI
- 00723896008782
- Version / Model
- 7129540
- Catalog Number
- 71-29540
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-19
- Public Version
- 2
- Public Version Date
- 2018-11-08
- Public Version Status
- Update
- Public Device Record Key
- 4c22fc7e-6bc8-40d1-af2a-b14023fc4ab6
Device Description
create superior anatomical features for composite or amalgam restorations in less time and with fewer instruments. Shape occlusal contours in composites before curing and reduce post-cure cutting for stronger restorations. Instrument features a 21B acorn burnisher on one end with two sizes of rounded pluggers on the other. Also excellent for shaping and burnishing amalgams. 3⁄8" diameter easy-grasp ultralight handle for maximum control and tactile sensitivity. 6-3⁄4" long. Fully sterilizable stainless steel.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35697 | Dental material application tool, single-use | A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00723896008782 | GS1 |