DenQ Sub SLA Fixture II

Primary DI
08800131003800
Brand
DenQ Sub SLA Fixture II
Company
DenQ Co.,Ltd.
Model
DSSDW70120S
Catalog number
DSSDW70120S
Device description
6.8x12.0, Bone level
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K240977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240977000DenQ Sub SLA Implant SystemDenq2024-09-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800131003800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800131003800088001310038008800131003800

GMDN Terms#

Term, Definition table
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#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82-7046473643s@denq.co.kr

Regulatory Flags#

DUNS number
695155534
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880131035528DenQ Sub Cement AbutmentDSCR45504DSDSCR45504DS2026-03-06
08800131035146DenQ Sub Cement AbutmentDSCR40104DSDSCR40104DS2026-03-06
08800131035153DenQ Sub Cement AbutmentDSCR40154DSDSCR40154DS2026-03-06
08800131035160DenQ Sub Cement AbutmentDSCR40204DSDSCR40204DS2026-03-06
08800131035177DenQ Sub Cement AbutmentDSCR40254DSDSCR40254DS2026-03-06
08800131035184DenQ Sub Cement AbutmentDSCR40304DSDSCR40304DS2026-03-06
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

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