FDA.reportPublic FDA data

Healing Abutment

Primary DI
D890HAH5060
Brand
Healing Abutment
Company
SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.
Model
HAH506
Device description
Healing Abutment Hex 5.0mm H 6mm
Published
2019-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170372000SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.2017-06-30DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D890HAH5060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA 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 includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
086863437
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D890HACNP3830Healing Abutment HACNP3832019-09-06
D890HACNP3840Healing AbutmentHACNP3842019-09-06
D890HACNP3860Healing AbutmentHACNP3862019-09-06
D890HACNP45040Healing Abutment HACNP45042019-09-06
D890HACNP4530Healing Abutment HACNP4532019-09-06
D890HACNP4560Healing Abutment HACNP4562019-09-06
D890HACRP3830Healing Abutment HACRP3832019-09-06
D890HACRP3840Healing AbutmentHACRP3842019-09-06
D890HACRP3860Healing AbutmentHACRP3862019-09-06
D890HACRP5030Healing Abutment HACRP5032019-09-06
D890HACRP5040Healing Abutment HACRP5042019-09-06
D890HACRP5060Healing Abutment HACRP5062019-09-06
D890HACRP6030Healing Abutment HACRP6032019-09-06
D890HACRP6040Healing Abutment HACRP6042019-09-06
D890HACSP3530Healing AbutmentHACSP3532019-09-06
D890HACSP3540Healing AbutmentHACSP3542019-09-06
D890HACSP3560Healing Abutment HACSP3562019-09-06
D890HACSP4530Healing Abutment HACSP4532019-09-06
D890HACSP4540Healing AbutmentHACSP4542019-09-06
D890HACSP4560Healing Abutment HACSP4562019-09-07

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Primary DI, Brand, Company table
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