FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Preference Soft Denture Liner
DI: D040200118602
·
Model: Silicone Tube 12 oz.
·
WHIP-MIX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Preference Soft Denture Liner
- Primary DI
- D040200118602
- Version / Model
- Silicone Tube 12 oz.
- Catalog Number
- 20011860
- Company Name
- WHIP-MIX CORPORATION
- Labeler DUNS
- 006385173
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 4
- Public Version Date
- 2019-07-31
- Public Version Status
- Update
- Public Device Record Key
- 7d94894c-1517-408b-a631-356f6b01ff9d
- Distribution End Date
- 2019-06-06
Device Description
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17610 | Denture reliner, soft, professional | A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). 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 | D040200118602 | HIBCC |
Customer Contacts
- Phone
- 5026345357
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140146 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12 oz. |