FDA UDI
In Commercial Distribution
🇺🇸 United States
Affinity™ Heavy Body FS 12-Pack
DI: 00359883001636
·
Model: 013952
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Affinity™ Heavy Body FS 12-Pack
- Primary DI
- 00359883001636
- Version / Model
- 013952
- Catalog Number
- 013952
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 1
- Public Version Date
- 2025-03-20
- Public Version Status
- New
- Public Device Record Key
- 39be30f8-0744-4f2b-b1dd-07710eb23c63
Device Description
VPS Impression Material
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00359883001629 | GS1 | ||||
| Primary | 00359883001636 | GS1 |
Customer Contacts
- Phone
- +1(800)433-6628
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053014 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 50 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 65 – 75 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Min Relative Humidity. Ensure Adequate Ventilation