Multi Bond

GUDID 07290115050158

B.J.M. LABORATORIES LTD

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

Primary Device ID	07290115050158
NIH Device Record Key	a241229d-eb60-4797-9c11-7af1d0f9bd69
Commercial Distribution Status	In Commercial Distribution
Brand Name	Multi Bond
Version Model Number	100047
Company DUNS	514764117
Company Name	B.J.M. LABORATORIES LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Dimensions

Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter
Total Volume	2 Milliliter

Operating and Storage Conditions

Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius
Storage Environment Temperature	Between 0 and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290115050158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K933766

FDA Product Code

KLE	AGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-30
Device Publish Date	2023-11-22

On-Brand Devices [Multi Bond]

07290115050158	100047
07290115050141	100046