FDA.reportPublic FDA data

XP-I SLA Fixture

Primary DI
08800041365463
Brand
XP-I SLA Fixture
Company
sewon medix Inc.
Model
BIH2FM3513S
Catalog number
BIH2FM3513S
Device description
SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x13.0mm
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
08800041365463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800041365463088000413654638800041365463

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
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
07630031742124Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742131Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742148Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742155Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742162Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742179Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742186Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742193Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742209Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742216Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742223Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742230Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742247Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742254Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742407Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742414Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742421Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742438Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742445Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742452Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742469Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742476Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742483Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742490Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742506Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742513Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742520Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742537Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742612Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742629Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06