FDA.report

DenQ Sub SLA Fixture I

Primary DI
08800131001554
Brand
DenQ Sub SLA Fixture I
Company
DenQ Co.,Ltd.
Model
DSSR50075S
Catalog number
DSSR50075S
Device description
5.1x7.5, Bone level
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions

SubmissionSupplement
K240977000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240977000DenQ Sub SLA Implant SystemDenq2024-09-13DZE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800131001554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800131001554088001310015548800131001554

GMDN Terms

TermDefinition
Basket 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 single, double, and/or triple contiguous cylinder(s) 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.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+82-7046473643s@denq.co.kr

Regulatory Flags

DUNS number
695155534
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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08800131035146DenQ Sub Cement AbutmentDSCR40104DSDSCR40104DS2026-03-06
08800131035153DenQ Sub Cement AbutmentDSCR40154DSDSCR40154DS2026-03-06
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08800131035191DenQ Sub Cement AbutmentDSCR40354DSDSCR40354DS2026-03-06
08800131035207DenQ Sub Cement AbutmentDSCR40404DSDSCR40404DS2026-03-06
08800131035214DenQ Sub Cement AbutmentDSCR40454DSDSCR40454DS2026-03-06
08800131035221DenQ Sub Cement AbutmentDSCR40504DSDSCR40504DS2026-03-06
08800131035238DenQ Sub Cement AbutmentDSCR40055DSDSCR40055DS2026-03-06
08800131035245DenQ Sub Cement AbutmentDSCR40105DSDSCR40105DS2026-03-06
08800131035252DenQ Sub Cement AbutmentDSCR40155DSDSCR40155DS2026-03-06
08800131035269DenQ Sub Cement AbutmentDSCR40205DSDSCR40205DS2026-03-06
08800131035276DenQ Sub Cement AbutmentDSCR40255DSDSCR40255DS2026-03-06
08800131035283DenQ Sub Cement AbutmentDSCR40305DSDSCR40305DS2026-03-06
08800131035290DenQ Sub Cement AbutmentDSCR40355DSDSCR40355DS2026-03-06
08800131035306DenQ Sub Cement AbutmentDSCR40405DSDSCR40405DS2026-03-06
08800131035313DenQ Sub Cement AbutmentDSCR40455DSDSCR40455DS2026-03-06
08800131035320DenQ Sub Cement AbutmentDSCR40505DSDSCR40505DS2026-03-06

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