FDA.report

Max

Primary DI
D76815868K0
Brand
Max
Company
KEYSTONE DENTAL, INC.
Model
15868K
Device description
Implant
Published
2018-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D76815868K0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)902-9272info@keystonedental.com

Regulatory Flags

DUNS number
787471015
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
true
Sterilization required before use
false

Other Devices From This Company

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D768G151000Genesis ACTIVEG151002023-06-19
D768G151010Genesis ACTIVEG151012023-06-19
D768G151020Genesis ACTIVEG151022023-06-19
D768G151030Genesis ACTIVEG151032023-06-19
D768G151040Genesis ACTIVEG151042023-06-19
D768G151050Genesis ACTIVEG151052023-06-19
D768G151060Genesis ACTIVEG151062023-06-19
D768G151070Genesis ACTIVEG151072023-06-19
D768G151080Genesis ACTIVEG151082023-06-19
D768G151090Genesis ACTIVEG151092023-06-19
D768G151100Genesis ACTIVEG151102023-06-19
D768G151110Genesis ACTIVEG151112023-06-19
D768G151120Genesis ACTIVEG151122023-06-19
D768G151130Genesis ACTIVEG151132023-06-19
D768G151140Genesis ACTIVEG151142023-06-19
D768G151150Genesis ACTIVEG151152023-06-19
D768G151160Genesis ACTIVEG151162023-06-19
D768G151170Genesis ACTIVEG151172023-06-19
D768G151180Genesis ACTIVEG151182023-06-19
D768G151200Genesis ACTIVEG151202023-06-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100118DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100125DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100132DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100149DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100156DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100163DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100170DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100187DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100194DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100200DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100217DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100224DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100231DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100248DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100255DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100262DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20