Forma S 5686

GUDID 00883205038104

Forma Global Compule Refill Trans/Incisal - 10 x 0.2g Capsules

ULTRADENT PRODUCTS, INC.

Dental composite resin
Primary Device ID00883205038104
NIH Device Record Keyd7f1c364-6a8e-4f33-ba40-206c3d0cb090
Commercial Distribution StatusIn Commercial Distribution
Brand NameForma S
Version Model Number5686
Catalog Number5686
Company DUNS013369913
Company NameULTRADENT PRODUCTS, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205038104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

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00883205037923Forma Global Compule Refill A2D - 10 x 0.2g Capsules
00883205037916Forma Global Compule Refill A2B - 10 x 0.2g Capsules
00883205037909Forma Global Compule Refill A1E - 10 x 0.2g Capsules
00883205037893Forma Global Compule Refill A1D - 10 x 0.2g Capsules
00883205037886Forma Global Compule Refill A1B - 10 x 0.2g Capsules
00883205037862Forma Global Syringe Refill Opaquer - 4g Syringe
00883205037855Forma Global Syringe Refill BL2 - 4g Syringe
00883205037848Forma Global Syringe Refill BL1 - 4g Syringe
00883205037831Forma Global Syringe Refill XWE - 4g Syringe
00883205037817Forma Global Syringe Refill WE - 4g Syringe
00883205037800Forma Global Syringe Refill WD - 4g Syringe
00883205037787Forma Global Syringe Refill Trans/Incisal - 4g Syringe
00883205037695Forma Global Syringe Refill B1B - 4g Syringe
00883205037664Forma Global Syringe Refill A3E - 4g Syringe
00883205037657Forma Global Syringe Refill A3D - 4g Syringe
00883205037640Forma Global Syringe Refill A3B - 4g Syringe
00883205037626Forma Global Syringe Refill A3.5B - 4g Syringe
00883205037619Forma Global Syringe Refill A2E - 4g Syringe
00883205037602Forma Global Syringe Refill A2D - 4g Syringe
00883205037596Forma Global Syringe Refill A2B - 4g Syringe
00883205037589Forma Global Syringe Refill A1E - 4g Syringe
00883205037572Forma Global Syringe Refill A1D - 4g Syringe
00883205037565Forma Global Syringe Refill A1B - 4g Syringe
00883205039767Forma Global Compule Refill C2D - 10 x 0.2g Capsules
00883205039750Forma Global Compule Refill B1D - 10 x 0.2g Capsules
00883205038210Forma Global Capsule Refill Kit - 0.2g Capsules
00883205038197Forma Global Sample Capsule Kit - 3 x 0.2g Capsules (A2B)
00883205038180Forma Global Compule Refill Opaquer - 10 x 0.2g Capsules
00883205038173Forma Global Compule Refill BL2 - 10 x 0.2g Capsules
00883205038166Forma Global Compule Refill BL1 - 10 x 0.2g Capsules
00883205038159Forma Global Compule Refill XWE - 10 x 0.2g Capsules
00883205038135Forma Global Compule Refill WE - 10 x 0.2g Capsules
00883205038128Forma Global Compule Refill WD - 10 x 0.2g Capsules
00883205038104Forma Global Compule Refill Trans/Incisal - 10 x 0.2g Capsules
00883205038012Forma Global Compule Refill B1B - 10 x 0.2g Capsules
00883205037985Forma Global Compule Refill A3E - 10 x 0.2g Capsules
00883205037978Forma Global Compule Refill A3D - 10 x 0.2g Capsules
00883205037961Forma Global Compule Refill A3B - 10 x 0.2g Capsules
00883205037947Forma Global Compule Refill A3.5B - 10 x 0.2g Capsules
00883205037930Forma Global Compule Refill A2E - 10 x 0.2g Capsules
00883205037879Forma Global Sample Syringe Kit - 1g Syringe (A2B)
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