Primary Device ID | 00883205037053 |
NIH Device Record Key | 2f216f01-25b0-49fc-9585-e6b91c89dea1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Amelogen Plus |
Version Model Number | 8020 |
Catalog Number | 8020 |
Company DUNS | 013369913 |
Company Name | ULTRADENT PRODUCTS, 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 | true |
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 |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com | |
Phone | +1(801)572-4200 |
customerservice@ultradent.com |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00883205037053 [Primary] |
EBF | Material, tooth shade, resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-30 |
Device Publish Date | 2023-08-22 |
00883205107237 | Amelogen Plus Syringe Trans Orange Refill |
00883205107220 | Amelogen Plus Syringe Trans Gray Refill |
00883205107213 | Amelogen Plus Syringe Trans White Refill |
00883205107206 | Amelogen Plus Syringe Enamel Gray Refill |
00883205107190 | Amelogen Plus Syringe Enamel Neutral Refill |
00883205107183 | Amelogen Plus Syringe Enamel White Refill |
00883205107176 | Amelogen Plus Syringe Opaque White Refill |
00883205107169 | Amelogen Plus Syringe C2 Refill |
00883205107152 | Amelogen Plus Syringe B1 Refill |
00883205107145 | Amelogen Plus Syringe A5 Refill |
00883205107138 | Amelogen Plus Syringe A4 Refill |
00883205107121 | Amelogen Plus Syringe A3 Refill |
00883205107114 | Amelogen Plus Syringe A2 Refill |
00883205107107 | Amelogen Plus Syringe A1 Refill |
00883205107091 | Amelogen Plus Syringe A3.5 Refill |
00883205107053 | Amelogen Plus Singles Super Light 10pk |
00883205107046 | Amelogen Plus Singles A3.5 10pk |
00883205107039 | Amelogen Plus Singles Enamel Neutral 10pk |
00883205107022 | Amelogen Plus Singles Enamel White 10pk |
00883205107015 | Amelogen Plus Singles Opaque White 10pk |
00883205107008 | Amelogen Plus Singles C2 10pk |
00883205106995 | Amelogen Plus Singles Trans Orange 10pk |
00883205106988 | Amelogen Plus Singles Trans Gray 10pk |
00883205106971 | Amelogen Plus Singles B1 10pk |
00883205106964 | Amelogen Plus Singles Trans White 10pk |
00883205106957 | Amelogen Plus Singles A5 10pk |
00883205106940 | Amelogen Plus Singles A4 10pk |
00883205106933 | Amelogen Plus Singles A3 10pk |
00883205106926 | Amelogen Plus Singles Enamel Gray 10pk |
00883205106919 | Amelogen Plus Singles A2 10pk |
00883205106902 | Amelogen Plus Singles A1 10pk |
00883205106681 | Amelogen Plus Singles Complete Kit |
00883205106667 | Amelogen Plus Syringe Complete Kit |
00883205106650 | Amelogen Plus Basic Singles Kit |
00883205106612 | Amelogen Plus Syringe Basic Kit |
00883205106544 | Amelogen Plus Syringe Natural Kit |
00883205105516 | Amelogen Plus Syringe Cosmetic Kit |
00883205101266 | AMELOGEN PLUS HANDS-ON KIT |
00883205027320 | Amelogen Plus Syringe Cosmetic Kit |
00883205027313 | Amelogen Plus Syringe Basic Kit |
00883205037268 | Amelogen Plus Hands-On Kit |
00883205037251 | Amelogen Plus Syringe Trans Orange Refill |
00883205037244 | Amelogen Plus Syringe Trans Gray Refill |
00883205037237 | Amelogen Plus Syringe Trans White Refill |
00883205037220 | Amelogen Plus Syringe Enamel Gray Refill |
00883205037213 | Amelogen Plus Syringe Enamel Neutral Refill |
00883205037206 | Amelogen Plus Syringe Enamel White Refill |
00883205037190 | Amelogen Plus Syringe Opaque White Refill |
00883205037183 | Amelogen Plus Syringe C2 Refill |
00883205037176 | Amelogen Plus Syringe B1 Refill |