FDA.report

DenQ Sub Cement Abutment

Primary DI
08800131035160
Brand
DenQ Sub Cement Abutment
Company
DenQ Co.,Ltd.
Model
DSCR40204DS
Catalog number
DSCR40204DS
Device description
Cement (Ø4.0x2.0x4) + Sub Abutment Screw
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions

SubmissionSupplement
K240977000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800131035160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800131035160088001310351608800131035160

GMDN Terms

TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00880131035528DenQ Sub Cement AbutmentDSCR45504DSDSCR45504DS2026-03-06
08800131035146DenQ Sub Cement AbutmentDSCR40104DSDSCR40104DS2026-03-06
08800131035153DenQ Sub Cement AbutmentDSCR40154DSDSCR40154DS2026-03-06
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
08800131035337DenQ Sub Cement AbutmentDSCR40057DSDSCR40057DS2026-03-06

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