FDA.reportPublic FDA data

UltraSeal XT

Primary DI
00883205101310
Brand
UltraSeal XT
Company
ULTRADENT PRODUCTS, INC.
Model
3530
Catalog number
3530
Device description
UltraSeal XT Hydro Unit Dose 50pk OP White
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112517000ULTRASEAL XT HYDROUltradent Products, Inc.2011-09-23EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205101310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205101310008832051013108832051013100883205101310

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius29 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
013369913
Device count
1
Lot or batch
true
Expiration date on label
true

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00883205029133OpalDam324-U324-U2026-08-22
00883205029140OpalDam325-U325-U2026-08-22
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00883205041005Thermo Clone606560652026-08-22
00883205041883UltraCem205620562026-08-22
00883205043221ViscoStat Clear640764072026-08-22
00883205043238ViscoStat Clear640864082026-08-22
00883205043245ViscoStat Clear640964092026-08-22
00883205043252ViscoStat Clear641064102026-08-22
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00883205044624Halo Sectional Matrix System993299322026-06-26
00883205044631Halo Sectional Matrix System993399332026-06-26

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