FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DHPI Health-Tec Dental Amalgam Alloy
DI: D773100UTT15001
·
Model: 100-UTT1500
·
Dental Health Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- DHPI Health-Tec Dental Amalgam Alloy
- Primary DI
- D773100UTT15001
- Version / Model
- 100-UTT1500
- Catalog Number
- 100-UTT1500
- Company Name
- Dental Health Products Inc
- Labeler DUNS
- 623191194
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2017-01-24
- Public Version
- 4
- Public Version Date
- 2022-09-30
- Public Version Status
- Update
- Public Device Record Key
- f538e92f-7c4e-4404-bc1b-b0e4bc27d5c0
- Distribution End Date
- 2022-09-30
Device Description
DHPI Health Tec High Copper Spherical Single Spill
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
- 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 |
|---|---|---|---|---|
| EJJ | Alloy, Amalgam | Dental | 872.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16367 | Dental amalgam | A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. 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 | D773100UTT15001 | HIBCC | ||||
| Unit of Use | D773100UTT15000 | HIBCC |
Customer Contacts
- Phone
- 800-626-2163
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951865 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 400 | Milligram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 25 Degrees Celsius