FDA.reportPublic FDA data

PressCeramic

Primary DI
07630716600695
Brand
PressCeramic
Company
DSSM AG
Model
753574
Catalog number
753574
Device description
PressCeramic HT B4 (4)
Published
2026-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
07630716600695PrimaryGS10
07630716616528Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630716600695076307166006957630716600695
07630716616528076307166165287630716616528

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Regulatory Flags#

DUNS number
448425186
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630716600619PressCeramic7535667535662026-07-07
07630716600626PressCeramic7535677535672026-07-07
07630716600633PressCeramic7535687535682026-07-07
07630716600640PressCeramic7535697535692026-07-07
07630716600657PressCeramic7535707535702026-07-07
07630716600664PressCeramic7535717535712026-07-07
07630716600671PressCeramic7535727535722026-07-07
07630716600688PressCeramic7535737535732026-07-07
07630716600701PressCeramic7535757535752026-07-07
07630716600718PressCeramic7535767535762026-07-07
07630716600725PressCeramic7535777535772026-07-07
07630716600732PressCeramic7535787535782026-07-07
07630716600749PressCeramic7535797535792026-07-07
07630716600756PressCeramic7535807535802026-07-07
07630716600763PressCeramic7535817535812026-07-07
07630716600770PressCeramic7535827535822026-07-07
07630716600787PressCeramic7535837535832026-07-07
07630716600794PressCeramic7535847535842026-07-07
07630716600800PressCeramic7535857535852026-07-07
07630716600817PressCeramic7535867535862026-07-07

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Primary DI, Brand, Company table
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