FDA.reportPublic FDA data

INNO SLA Submerged Implant System-Impression Coping

Primary DI
08809471723621
Brand
INNO SLA Submerged Implant System-Impression Coping
Company
Cowellmedi Co.,Ltd
Model
SINR001
Published
2024-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809471723621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809471723621088094717236218809471723621

GMDN Terms#

Term, Definition table
TermDefinition
Dental precision attachment simulator/analog, single-useA device intended to be used to imitate or copy a dental precision attachment, or element that is part of a precision attachment, during fabrication of a final dental prosthesis (e.g., denture, crown, bridge) in the dental laboratory. It may be an instrument designed to reproduce the position, shape, and dimensions of a precision attachment, or it may be a copy of a precision attachment designed to enable fabrication of, or correct incorporation of, the final precision attachment in the dental prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688753763
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800016115994Screw KitKIGICS0012026-03-20
08800016163070Dental InstrumentSSFSS100N2026-01-29
08800016176841Dental InstrumentKSRIG25R2026-01-29
08800016176858Dental InstrumentKSRIG21N2026-01-29
08800016176865Dental InstrumentKTW0032026-01-29
08800016101362Dental InstrumentKRMSD10S2026-01-28
08800016114256Dental Implants Accesseories-Single UseSSB100SN2026-01-28
08800016114447Dental InstrumentKMTD18S2026-01-28
08800016114454Dental InstrumentKMTD18L2026-01-28
08800016114461Dental InstrumentKHTD18082026-01-28
08800016114478Dental InstrumentKHTD18202026-01-28
08800016114485Dental InstrumentKHTD18152026-01-28
08800016115024Dental InstrumentKRBUD082026-01-28
08800016115840Dental InstrumentKMATD18S2026-01-28
08800016115857Dental InstrumentKMATD18L2026-01-28
08800016116014Dental InstrumentKHSPLD01S2026-01-28
08800016117769SFIT Crown GaugeSFCG2026-01-28
08800016117783Dental Implants Accesseories-Single Use2SSB100S2026-01-28
08800016144772Dental InstrumentKHSPLD01L2026-01-28
08800016146530Dental Implants Accesseories-Reusable2SMTN5552026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481138218LOCATOR FixedZest Anchors, LLCNHA2026-05-22
00840481138225LOCATOR FixedZest Anchors, LLCNHA2026-05-22
00840481138232LOCATOR FixedZest Anchors, LLCNHA2026-05-22
07290120481039IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120481237IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120481435IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482470IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482524IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482579IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482623IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482678IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486621NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486676NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486720NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486775NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486829NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486973RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487024RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487079RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487383NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487437RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487482RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487529IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487536NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487628IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487727IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487826IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488328IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24