FDA.reportPublic FDA data

XP-I SLA Fixture

Primary DI
08800041365135
Brand
XP-I SLA Fixture
Company
sewon medix Inc.
Model
AIH2FM3515S
Catalog number
AIH2FM3515S
Device description
SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x15.0mm
Published
2022-02-16
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

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
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
08800041365135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800041365135088000413651358800041365135

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, single-useA sterile shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688731065
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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
08800041365296XP-I SLA FixtureAIH2FR4511SAIH2FR4511S2022-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08809822767892AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767908AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12