FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Henry Schein® Eugenol, USP
DI: D6871710504FG2
·
Model: 1710504FG
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Henry Schein® Eugenol, USP
- Primary DI
- D6871710504FG2
- Version / Model
- 1710504FG
- Catalog Number
- 1710504FG
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2022-09-30
- Public Version Status
- Update
- Public Device Record Key
- adf6bf1d-c215-420b-b002-c80d448e55b1
- Distribution End Date
- 2019-01-09
Device Description
Henry Schein® Eugenol - 4 oz bottle
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EMB | ZINC OXIDE EUGENOL | Dental | 872.3275 | 1 |
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 | D6871710504FG2 | HIBCC | ||||
| Unit of Use | D6871710504FG0 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12 Bottles (4 oz each) | ||
| Total Volume | 4 | Fluid Ounce |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to temperatures above 95° F (35° C)