FDA.reportPublic FDA data

ESI

Primary DI
D890ESI35013A0
Brand
ESI
Company
SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.
Model
ESI35013A
Catalog number
ESI35013A
Device description
ESI Implant Hex 3.5mmx13mmSLA Surface
Published
2018-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
D890ESI35013A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13124407777info@spiraltech.com

Regulatory Flags#

DUNS number
086863437
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712705prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712712prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712729prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712736prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712743prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712750prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
08809984970420S-PlantIDIS CO.,LTDDZE2026-10-07
07290114712149prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712767prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712774prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712781prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712798prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712804prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712811prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712828prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712835prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712842prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712859prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712866prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712873prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712880prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712897prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712903prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712910prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712927prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712934prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712941prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06