FDA UDI
In Commercial Distribution
🇺🇸 United States
Buffalo Dental
DI: 00850043381587
·
Model: Pkg 12 118 EVA, Pkg 25 118 EVA, Pkg 100 118 EVA, Pkg 300 118 EVA
·
Buffalo Dental Manufacturing Co., Inc.
Product Codes
2
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- Buffalo Dental
- Primary DI
- 00850043381587
- Version / Model
- Pkg 12 118 EVA, Pkg 25 118 EVA, Pkg 100 118 EVA, Pkg 300 118 EVA
- Catalog Number
- 62815, 62816, 62805, 62810
- Company Name
- Buffalo Dental Manufacturing Co., Inc.
- Labeler DUNS
- 001372853
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-10
- Public Version
- 1
- Public Version Date
- 2026-04-20
- Public Version Status
- New
- Public Device Record Key
- 7dbc8124-d328-4345-b59b-229cbedbfe7c
Device Description
Pkg 12 118 EVA Pkg25 118 EVA Pkg 100 118 EVA Pkg 300 118 EVA
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBH | Material, Impression Tray, Resin | Dental | 872.3670 | 1 |
| KMT | Tray, Fluoride, Disposable | Dental | 872.6870 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58288 | Dental appliance fabrication material, thermoplastic | A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850043381631 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00850043381587 | GS1 | ||||
| Package | 00850043381648 | GS1 | Box | 25 | In Commercial Distribution | |
| Package | 00850043381655 | GS1 | Box | 100 | In Commercial Distribution | |
| Package | 00850043381679 | GS1 | Box | 300 | In Commercial Distribution |