FDA.reportPublic FDA data

Opal Seal

Primary DI
00883205103253
Brand
Opal Seal
Company
ULTRADENT PRODUCTS, INC.
Model
500060
Catalog number
500060
Device description
Opal Seal Intro Kit
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090355000OPAL SEALUltradent Products, Inc.2009-04-29DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205103253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205103253008832051032538832051032530883205103253

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
00883205104298Diamond Polish Mint554155412016-09-22
00883205104304Diamond Polish Mint554055402016-09-22
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
00883205041883UltraCem205620562026-08-22
00883205043221ViscoStat Clear640764072026-08-22
00883205043238ViscoStat Clear640864082026-08-22
00883205043245ViscoStat Clear640964092026-08-22
00883205043252ViscoStat Clear641064102026-08-22
00883205043344Valo X5973-DU5973-DU2026-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998062605SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062612SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062629SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062636SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062643SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062650SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062667SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062674SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062766SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062773SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062780SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062797SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062865SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062872SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062896SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064739SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064746SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067891SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067907SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067914SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067921SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067938SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067945SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067952SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067969SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067976SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067983SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069208SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069215SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069222SolventumSolventum Orthodontics CorporationDYH2026-11-04