DEVICE: Henry Schein® Eugenol, USP (D6871710504FG2)
Device Identifier (DI) Information
Henry Schein® Eugenol, USP
1710504FG
Not in Commercial Distribution
1710504FG
DENTSPLY INTERNATIONAL INC.
1710504FG
Not in Commercial Distribution
1710504FG
DENTSPLY INTERNATIONAL INC.
Henry Schein® Eugenol - 4 oz bottle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EMB | ZINC OXIDE EUGENOL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do not expose to temperatures above 95° F (35° C) |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 12 Bottles (4 oz each) |
Total Volume: 4 Fluid Ounce |
Device Record Status
adf6bf1d-c215-420b-b002-c80d448e55b1
September 30, 2022
3
September 21, 2016
September 30, 2022
3
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D6871710504FG0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
MilfordDE-Customer-Service@dentsplysirona.com