FDA.reportPublic FDA data

UltraSeal XT Hydro

Primary DI
00883205035202
Brand
UltraSeal XT Hydro
Company
ULTRADENT PRODUCTS, INC.
Model
5538
Catalog number
5538
Device description
UltraSeal XT Hydro Kit A2 Opaque Bioprotection by Nobio
Published
2023-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K232498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232498000UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.2023-08-18EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205035202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205035202008832050352028832050352020883205035202

GMDN Terms#

Term, Definition table
TermDefinition
Dental unfilled resin sealant/coatingA non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205004550ViscoStat ClearS646S6462018-04-28
00883205103192ViscoStat Clear641064102018-04-28
00883205103208ViscoStat Clear640964092018-04-28
00883205106889ViscoStat Clear640764072018-04-28
00883205106896ViscoStat Clear640864082018-04-28
00883205045775ClearTemp LC351835182026-04-28
00883205045782ClearTemp LCS3518S35182026-04-28
00883205045805Universal Dentin Sealant2662662026-04-28
00883205045904UltraSealS3529S35292026-04-28
00883205045911Peak Universal BondS4554S45542026-04-28
00883205045928Peak Universal BondS4551S45512026-04-28
00883205044990Porcelain Repair110811082026-03-28
00883205045003Porcelain Etch4054052026-03-28
00883205045010UltraSeal XT353235322026-03-28
00883205045027UltraSeal XT353335332026-03-28
00883205045034Peak Universal Bond454145412026-03-28
00883205045041Peak Universal Bond454245422026-03-28
00883205045058Peak Universal Bond455145512026-03-28
00883205045720Porcelain Etch101910192026-03-28
00883205042835Opalustre5545542026-03-10

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08806387860136Jet Flow Bulk DentinMeta Biomed Co., Ltd.EBC2024-11-16
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