FDA UDI
In Commercial Distribution
🇺🇸 United States
Patterson®
DI: D6620712583910
·
Model: 71258391
·
PATTERSON DENTAL SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Patterson®
- Primary DI
- D6620712583910
- Version / Model
- 71258391
- Catalog Number
- 71258391
- Company Name
- PATTERSON DENTAL SUPPLY, INC.
- Labeler DUNS
- 171843584
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-08
- Public Version
- 2
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- 55c97477-3e97-4785-962e-d8bc2e9dd3a6
Device Description
MATERIAL, TOOTH SHADE, RESIN
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
- No
- 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 |
|---|---|---|---|---|
| EBF | Material, tooth shade, resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34799 | Composite dental impression material | A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6620712583910 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182778 | 000 |