FDA.reportPublic FDA data

K2-HF SHOULDER, SH-3 T powder, 20g.

Primary DI
EYET38622020
Brand
K2-HF SHOULDER, SH-3 T powder, 20g.
Company
Yeti Dentalprodukte GmbH
Model
386-2202
Published
2026-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
EYET38622020PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
324001916
Device count
1
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
false
Expiration date on label
true
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
EYET38800000K2 MyStains Structure Set38800002026-05-20
EYET388000010K2 MyStains Structure Set388000012026-05-20
EYET38800230K2 MyStains ST-S13, uni red, 2g.38800232026-05-20
EYET38800240K2 MyStains ST-S14, uni gingiva, 2g.38800242026-05-20
EYET6530500M0 Sculp. Wax SPECIAL-Summer-Pink, Sample6530500M2026-05-20
EYET65505000 Sculp. Wax SPEZIAL winter Pink, Sample65505002026-05-20
EYET6550500M0 Sculp. Wax SPEZIAL winter Pink, Sample6550500M2026-05-20
EYET66005000 Sculp. Wax SUPERPINK elastic, Sample66005002026-05-20
EYET6600500M0 Sculp. Wax SUPERPINK elastic, Sample6600500M2026-05-20
EYET68000000SOLIDUS 80, base plate wax sheet, Sample68000002026-05-20
EYET6800000M0SOLIDUS 80, base plate wax sheet, Sample6800000M2026-05-20
EYET68400000 SOLIDUS 84 base plate wax sheet, Sample68400002026-05-20
EYET6840000M0 SOLIDUS 84 base plate wax sheet, Sample6840000M2026-05-20
EYET38780110K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.38780112026-05-11
EYET38780120K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.38780122026-05-11
EYET38780210K2 Li-Press-Pellets (HT-Hoch Transluzent) C1, 5x3g.38780212026-05-11
EYET38780310K2 Li-Press-Pellets (HT-Hoch Transluzent) BL1, 5x3g.38780312026-05-11
EYET38780320K2 Li-Press-Pellets (HT-Hoch Transluzent) BL3, 5x3g.38780322026-05-11
EYET38780330K2 Li-Press-Pellets (HT-Hoch Transluzent) BL2, 5x3g.38780332026-05-11
EYET38780340K2 Li-Press-Pellets (HT-Hoch Transluzent) BL4, 5x3g.38780342026-05-11

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