FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
00840326403587
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
J810
Catalog number
J810
Device description
Ora Pro G2 Lc Adhesive Syringe 5Gm
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326403584PackageGS11In Commercial Distribution
00840326403587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032640358410840326403584
00840326403587008403264035878403264035870840326403587

GMDN Terms#

Term, Definition table
TermDefinition
Dental acrylic resinA non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843471120460DefendVP-8104VP-81042022-10-30
00843471120477DefendVP-8104TVP-8104T2022-10-30
00843471120484DefendVP-8105VP-81052022-10-30
00843471120491DefendVP-8105TVP-8105T2022-10-30
00843471120514DefendVP-8106VP-81062022-10-30
00843471120521DefendVP-8106TVP-8106T2022-10-30
00843471120538DefendVP-8107VP-81072022-10-30
00843471120545DefendVP-8108VP-81082022-10-30
00843471120552DefendVP-8108TVP-8108T2022-10-30
00843471120569DefendVP-8111VP-81112022-10-30
00843471120576DefendVP-8111TVP-8111T2022-10-30
00843471120583DefendVP-8140VP-81402022-10-30
00843471120590DefendVP-8140TVP-8140T2022-10-30
00843471120606DefendVP-8150TVP-8150T2022-10-30
00843471120637DefendVP-8165TVP-8165T2022-10-30
00843471143926Defend2926272926272022-10-30
00843471152782DefendCS-0100CS-01002022-10-30
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998226731Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226748Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226755Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226762Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226823Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226847Solventum™ Garant™Solventum Germany GmbHEID2026-10-08
00810111542951AccessoryBISCO INC.EID2026-10-01
00883205041005Thermo CloneULTRADENT PRODUCTS, INC.EID2026-08-22
08800017902524EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
08800017902562EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
07615208353723Mixing TipsIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-08-19
00840456200940JMUJMU DENTAL, INCEID2026-07-20
00840456216743JMUJMU DENTAL, INCEID2026-07-20
00840456218198JMUJMU DENTAL, INCEID2026-07-20
00840456218204JMUJMU DENTAL, INCEID2026-07-20
07615208474398Clinical Auxiliary (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-07-14
08809518346721Disposable TipMEDICLUS CO.,LTDEID2026-06-05
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28