FDA.reportPublic FDA data

IH2 Healing Abutment

Primary DI
08800041302406
Brand
IH2 Healing Abutment
Company
sewon medix Inc.
Model
IHHAR605
Catalog number
IHHAR605
Device description
SEWON MEDIX IH Healing Abutment Regular, Ø6.0x5.0mm
Published
2019-07-19
Public version status
New
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
K153521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153521000IH Implant SystemSewonmedix, Inc.2016-10-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800041302406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800041302406088000413024068800041302406

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
688731065
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800041365098XP-I SLA FixtureAIH2FM3508SAIH2FM3508S2022-02-16
08800041365104XP-I SLA FixtureAIH2FM3510SAIH2FM3510S2022-02-16
08800041365111XP-I SLA FixtureAIH2FM3511SAIH2FM3511S2022-02-16
08800041365128XP-I SLA FixtureAIH2FM3513SAIH2FM3513S2022-02-16
08800041365135XP-I SLA FixtureAIH2FM3515SAIH2FM3515S2022-02-16
08800041365142XP-I SLA FixtureAIH2FR3507SAIH2FR3507S2022-02-16
08800041365159XP-I SLA FixtureAIH2FR3508SAIH2FR3508S2022-02-16
08800041365166XP-I SLA FixtureAIH2FR3510SAIH2FR3510S2022-02-16
08800041365173XP-I SLA FixtureAIH2FR3511SAIH2FR3511S2022-02-16
08800041365180XP-I SLA FixtureAIH2FR3513SAIH2FR3513S2022-02-16
08800041365197XP-I SLA FixtureAIH2FR3515SAIH2FR3515S2022-02-16
08800041365203XP-I SLA FixtureAIH2FR4007SAIH2FR4007S2022-02-16
08800041365210XP-I SLA FixtureAIH2FR4008SAIH2FR4008S2022-02-16
08800041365227XP-I SLA FixtureAIH2FR4010SAIH2FR4010S2022-02-16
08800041365234XP-I SLA FixtureAIH2FR4011SAIH2FR4011S2022-02-16
08800041365241XP-I SLA FixtureAIH2FR4013SAIH2FR4013S2022-02-16
08800041365258XP-I SLA FixtureAIH2FR4015SAIH2FR4015S2022-02-16
08800041365265XP-I SLA FixtureAIH2FR4507SAIH2FR4507S2022-02-16
08800041365272XP-I SLA FixtureAIH2FR4508SAIH2FR4508S2022-02-16
08800041365289XP-I SLA FixtureAIH2FR4510SAIH2FR4510S2022-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
05712821017123Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017130Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017147Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017154Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017161Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017178Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017185Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017192Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017208Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017215Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017222Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017239Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017246Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017253Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017260Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017277Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017284Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017291Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017307Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017321Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017338Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017345Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA0Omnibut, Hiossen Regular, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26