FDA.reportPublic FDA data

Opalpix

Primary DI
00883205031730
Brand
Opalpix
Company
ULTRADENT PRODUCTS, INC.
Model
5590
Catalog number
5590
Device description
Opalpix 32ct., 100pk
Published
2025-03-12
Public version status
New
Distribution status
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
JETPICK, MASSAGING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205031730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205031730008832050317308832050317300883205031730

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal pick/brush, reusableA manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
013369913
Device count
1
Premarket exempt
true
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800019151289PVS TipB& L Biotech, inc.JET2025-04-30
08800019151296PVS TipB& L Biotech, inc.JET2025-04-30
08800019151302PVS TipB& L Biotech, inc.JET2025-04-30
08800019151593DB TipB& L Biotech, inc.JET2025-04-30
08800019151609DB TipB& L Biotech, inc.JET2025-04-30
08800019151616DB TipB& L Biotech, inc.JET2025-04-30
08800019151623DB TipB& L Biotech, inc.JET2025-04-30
08800019151630DS TipB& L Biotech, inc.JET2025-04-30
08800019151647DS TipB& L Biotech, inc.JET2025-04-30
08800019151654DS TipB& L Biotech, inc.JET2025-04-30
08800019151661DS TipB& L Biotech, inc.JET2025-04-30
08800019151678TS TipB& L Biotech, inc.JET2025-04-30
08800019151685TS TipB& L Biotech, inc.JET2025-04-30
08800019151692TS TipB& L Biotech, inc.JET2025-04-30
08800019151708TS TipB& L Biotech, inc.JET2025-04-30
08800019151715TS TipB& L Biotech, inc.JET2025-04-30
08800019151722TS TipB& L Biotech, inc.JET2025-04-30
00070942008143GUM® SUNSTAR AMERICAS, INC.JET2025-01-08
08800019151517CI Tip B& L Biotech, inc.JET2024-12-16
08800019151524CI TipB& L Biotech, inc.JET2024-12-16
08800019151319DS TipB& L Biotech, inc.JET2024-12-05
08800019151326DS TipB& L Biotech, inc.JET2024-12-05
08800019151333DS TipB& L Biotech, inc.JET2024-12-05
08800019151340DS TipB& L Biotech, inc.JET2024-12-05
08800019151357DS TipB& L Biotech, inc.JET2024-12-05
08800019151364DS TipB& L Biotech, inc.JET2024-12-05
08800019151371DS TipB& L Biotech, inc.JET2024-12-05
08800019151388DS TipB& L Biotech, inc.JET2024-12-05
00070942007849GUM® SUNSTAR AMERICAS, INC.JET2024-10-30
00070942007498GUM SUNSTAR AMERICAS, INC.JET2024-10-04