FDA UDI
In Commercial Distribution
🇺🇸 United States
Duo:PCH®
DI: D8130329131801
·
Model: 032913180
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Duo:PCH®
- Primary DI
- D8130329131801
- Version / Model
- 032913180
- Catalog Number
- 032913180
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- c6814d5a-6ca9-40b7-8b48-76f28239cd0a
Device Description
DUO PCH LTRL XS 4pc #7&10 RFL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELL | Teeth, Porcelain | Dental | 872.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38645 | Dental veneer, professional | A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8130329131801 | HIBCC | ||||
| Unit of Use | D8130329131800 | HIBCC |
Customer Contacts
- Phone
- 1-800-433-6628
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K895269 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 33 – 75 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 33 – 75 Degrees Fahrenheit