FDA.reportPublic FDA data

Osseo 100

Primary DI
07350096320234
Brand
Osseo 100
Company
Integration Diagnostics Sweden AB
Model
Osseo 100 Set
Catalog number
Y1004175
Published
2022-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143445000Tellos ISQ BuddyTellos Medical AB2016-01-07EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350096320265Direct MarkingGS10
07350096320234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350096320265073500963202657350096320265
07350096320234073500963202347350096320234

GMDN Terms#

Term, Definition table
TermDefinition
MultimeterA battery-powered electronic instrument intended to be used to measure the amount or strength of values of an electric current, usually voltage and resistance. Sometimes, by means of additional probes, determinations such as sound level, or any form of energy that can be converted into an electrical signal, can be made.

Regulatory Flags#

DUNS number
352736781
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350096320272Osseo 100+Osseo 100+ InstrumentY10041762024-10-30
07350096322207MulTipeg™MulTipeg™ 100551342022-03-08
07350096321460MulTipeg™MulTipeg™ 38550462022-03-01
07350096320081Penguin RFAPenguin RFA Instrument Kit550022022-03-01
07350096320128Penguin RFAPenguin RFA Instrument Kit Implant Swiss55002-I2022-03-01
07350096320135Penguin RFAPenguin RFA Instrument Kit Klockner White55002-KW2022-03-08
07350096320142Penguin RFAPenguin RFA Instrument Kit Klockner Black55002-KB2022-03-08
07350096320159Penguin RFAPenguin RFA Instrument Kit Neoss55002-N2022-03-01
07350096320166Penguin RFAPenguin RFA Instrument Kit Citagenix55002-C2022-03-08
07350096320210Penguin RFAPenguin RFA Instrument Kit Bredent55002-B2022-03-08
07350096320241Penguin RFAIS3 Instrument Kit 55002-HM2022-03-08
07350096320319Penguin RFAPenguin RFA Instrument Kit SIC55002-S2022-03-08
07350096320333Penguin IIPenguin II Instrument552412023-12-20
07350096320395Penguin RFAPenguin RFA Instrument Kit OsseoFuse55002-O2022-03-08
07350096320418Penguin MDIPenguin MDI Instrument552802023-12-21
07350096320432MulTipeg™MDI MulTipeg™ 151552822023-12-21
07350096320449Penguin MDIPenguin MDI Locking Screwdriver552832023-12-21
07350096321606MulTipeg™MulTipeg™ 52550602022-03-08
07350096321613MulTipeg™MulTipeg™ 53550612022-03-08
07350096321620MulTipeg™MulTipeg™ 54550622022-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858466005257ENDOMAXDENTAMERICA, INC.EKX2026-04-22
00858466005240ENDOMAXDENTAMERICA, INC.EKX2026-04-21
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0006X-Smart® Go Contra-angle (6:1)FORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0007X-Smart® Go Protective silicone sleeveFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100BSPXSGOAC0005X-Smart® Go Power bankFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
09010522002674MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518334InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
09010522002575Osstell SmartPeg Type 113Osstell ABEKX2025-03-27
09010522002599Osstell SmartPeg Type 114Osstell ABEKX2025-03-27
09010522002612Osstell SmartPeg Type 115Osstell ABEKX2025-03-27
09010522002483SmartPeg Type 117Osstell ABEKX2024-05-15