FDA.reportPublic FDA data

Solventum™

Primary DI
00197998024252
Brand
Solventum™
Company
Solventum Germany GmbH
Model
69940
Catalog number
69940
Device description
Solventum™ Chairside Zirconia, 69940, BL, Crown Block, 5/PAC
Published
2026-05-08
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
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998024252PrimaryGS10
00197998080678Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998024252001979980242521979980242520197998024252
00197998080678001979980806781979980806780197998080678

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-2249regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
315518329
Device count
5
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
00197998296499Solventum™ Adaptic™201820182026-04-10
00197998296642Solventum™ Adaptic™201920192026-04-10
00197998296680Solventum™ Adaptic™201520152026-04-10
00197998296727Solventum™ Adaptic™201420142026-04-10
00197998296772Solventum™ Adaptic™201320132026-04-10
00197998296819Solventum™ Adaptic™201220122026-04-10
00197998118654Solventum™ Promogran Prisma™MA032MA0322026-04-10
00197998175190Solventum™ Promogran Prisma™PS2123PS21232026-04-10
00197998291128Solventum™ Promogran Prisma™MA123MA1232026-04-10
00197998291166Solventum™ Promogran Prisma™MA028MA0282026-04-10
00197998291203Solventum™ Promogran Prisma™PS2028PS20282026-04-10
00197998018930Solventum™36716367162026-05-08
00197998018947Solventum™36717367172026-05-08
00197998022579Solventum™76310763102026-05-08
00197998024269Solventum™41928419282026-05-08
00197998024276Solventum™41925419252026-05-08
00197998024290Solventum™41926419262026-05-08
00197998024306Solventum™69952699522026-05-08
00197998024313Solventum™69951699512026-05-08
00197998024320Solventum™69950699502026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011254000020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254000100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254000500ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254001020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254001100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254001500ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254002020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254002100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254002500ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254004020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254004100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254006020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254006100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254008020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254008100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254010020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254010100ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254012020Triceram®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254014020Triceram®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254300020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254301020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254302020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254303020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
J011254304020ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-07-25
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06942629805298Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805526Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805755Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805984Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805090Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21