Aelite All-Purpose Body H-812A3

GUDID D757H812A30

Dental composite resin

Primary Device ID	D757H812A30
NIH Device Record Key	44edcaf6-a922-4e96-9e1e-4a99ec87eb7c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Aelite All-Purpose Body
Version Model Number	H-812A3
Catalog Number	H-812A3
Company DUNS	053529939
Company Name	BISCO INC.
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	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	D757H812A30 [Primary]

EBF	MATERIAL, TOOTH SHADE, RESIN

Steralize Prior To Use	false
Device Is Sterile	false

D757H814B1P1	Aelite All-Purpose Body B1 15ct Unit Dose (0.25g ea) Pkg
D757H814B10	Aelite All-Purpose Body B1 15ct Unit Dose (0.25g ea)
D757H814A3P1	Aelite All-Purpose Body A3 15ct Unit Dose (0.25g ea) Pkg
D757H814A35P1	Aelite All-Purpose Body A3.5 15ct Unit Dose (0.25g ea) Pkg
D757H814A350	Aelite All-Purpose Body A3.5 15ct Unit Dose (0.25g ea)
D757H814A30	Aelite All-Purpose Body A3 15ct Unit Dose (0.25g ea)
D757H814A2P1	Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea) Pkg
D757H814A20	Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea)
D757H814A1P1	Aelite All-Purpose Body A1 15ct Unit Dose (0.25g ea) Pkg
D757H814A10	Aelite All-Purpose Body A1 15ct Unit Dose (0.25g ea)
D757H812B1P1	Aelite All-Purpose Body B1 4g Syringe Pkg
D757H812B10	Aelite All-Purpose Body B1 4g Syringe
D757H812A3P1	Aelite All-Purpose Body A3 4g Syringe Pkg
D757H812A35P1	Aelite All-Purpose Body A3.5 4g Syringe Pkg
D757H812A350	Aelite All-Purpose Body A3.5 4g Syringe
D757H812A30	Aelite All-Purpose Body A3 4g Syringe
D757H812A2P1	Aelite All-Purpose Body A2 4g Syringe Pkg
D757H812A20	Aelite All-Purpose Body A2 4g Syringe
D757H812A1P1	Aelite All-Purpose Body A1 4g Syringe Pkg
D757H812A10	Aelite All-Purpose Body A1 4g Syringe
10810111541746	Aelite All-Purpose Body B1 4g Syringe
10810111541722	Aelite All-Purpose Body A3 4g Syringe
10810111541715	Aelite All-Purpose Body A2 4g Syringe
10810111541708	Aelite All-Purpose Body A1 4g Syringe
20810111541767	Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea)