FDA.reportPublic FDA data

UltraCem

Primary DI
00883205041883
Brand
UltraCem
Company
ULTRADENT PRODUCTS, INC.
Model
2056
Catalog number
2056
Device description
UltraCem Bottles Kit
Published
2026-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205041883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205041883008832050418838832050418830883205041883

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205104205Composite Wetting Resin305930592016-09-22
00883205046086Opalescence6295-US6295-US2026-08-29
00883205102652UltraEZ574357432016-09-22
06944843624365Ultrapro TX Cordless5275-5275-2026-09-19
00883205026286Ultrapro TxS8303S83032026-08-22
00883205029102OpalDam1824-U1824-U2026-08-22
00883205029119OpalDam1825-U1825-U2026-08-22
00883205029126OpalDam1826-U1826-U2026-08-22
00883205029133OpalDam324-U324-U2026-08-22
00883205029140OpalDam325-U325-U2026-08-22
00883205029157OpalDam326-U326-U2026-08-22
00883205041005Thermo Clone606560652026-08-22
00883205043221ViscoStat Clear640764072026-08-22
00883205043238ViscoStat Clear640864082026-08-22
00883205043245ViscoStat Clear640964092026-08-22
00883205043252ViscoStat Clear641064102026-08-22
00883205043344Valo X5973-DU5973-DU2026-08-22
00883205031976STARbrush109310932024-12-07
00883205040398Halo Sectional Matrix System588358832026-06-26
00883205040978Halo Sectional Matrix System588258822026-06-26

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Primary DI, Brand, Company table
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00842326128149DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128156DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128163DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128170DuraflexThe Myerson Company LimitedEBI2026-10-22
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06942480722291FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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