SciPharm Band Secure Orthodontic Band Cement 62-011

GUDID D801SP62011N1

Band Secure - Orthodontic Band Cement with Fluoride. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dentine adhesive Dentine adhesive
Primary Device IDD801SP62011N1
NIH Device Record Key163a8584-b180-4193-9c54-1bf2eff4e1a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm Band Secure Orthodontic Band Cement
Version Model NumberSP 62-011 N
Catalog Number62-011
Company DUNS096010525
Company NameSCIENTIFIC PHARMACEUTICALS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-634-3047
EmailDenise@scipharm.com
Phone800-634-3047
EmailDenise@scipharm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD801SP62011N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-10

On-Brand Devices [SciPharm Band Secure Orthodontic Band Cement]

D801SP62011N1Band Secure - Orthodontic Band Cement with Fluoride. Non-Boxed.
D801SP62011B1Band Secure - Orthodontic Band Cement with Fluoride. Boxed.
D801SP62011Band Secure - Orthodontic Band Cement with Fluoride.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.