FDA.reportPublic FDA data

DenQ Sub Multi-unit Abutment(Straight)

Primary DI
08800131062180
Brand
DenQ Sub Multi-unit Abutment(Straight)
Company
DenQ Co.,Ltd.
Model
DSMR48402S
Catalog number
DSMR48402S
Device description
Multi-unit(Straight Ø4.0x4.0) + Carrier
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

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
08800131062180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800131062180088001310621808800131062180

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800131062166DenQ Sub Multi-unit Abutment(Straight)DSMR48302SDSMR48302S2026-08-25
08800131062203DenQ Sub Multi-unit Abutment(Straight)DSMR48502SDSMR48502S2026-08-25
08800131062463DenQ Sub Multi-unit Abutment(Angled-1)DSMAR493017ODSMAR493017O2026-08-25
08800131062470DenQ Sub Multi-unit Abutment(Angled-1)DSMAR494017ODSMAR494017O2026-08-25
08800131062494DenQ Sub Multi-unit Abutment(Angled-1)DSMAR494030ODSMAR494030O2026-08-25
08800131062807DenQ Sub Multi-unit Abutment(Angled-1)DSMAR493017OSDSMAR493017OS2026-08-25
08800131062814DenQ Sub Multi-unit Abutment(Angled-1)DSMAR494017OSDSMAR494017OS2026-08-25
08800131062838DenQ Sub Multi-unit Abutment(Angled-1)DSMAR494030OSDSMAR494030OS2026-08-25
08800131063101DenQ Sub Multi-unit Healing CapMHC48MHC482026-08-25
08800131063422DenQ Sub Multi-unit Temporary CylinderMTC480SMTC480S2026-08-25
08800131092064DenQ Sub Multi-unit Pick-up Impression copingMPIC480SMPIC480S2026-08-25
08800131098264DenQ Sub Multi-unit Lab AnalogDMLA480DMLA4802026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998744ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998751ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998775ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998805ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998812ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04