FDA.reportPublic FDA data

Penguin II

Primary DI
07350096320340
Brand
Penguin II
Company
Integration Diagnostics Sweden AB
Model
Penguin II Instrument
Catalog number
55241
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07350096320340PackageGS11In Commercial Distribution
07350096320371PackageGS11In Commercial Distribution
07350096320456PackageGS11In Commercial Distribution
07350096320463PackageGS11In Commercial Distribution
07350096320470PackageGS11In Commercial Distribution
07350096320487PackageGS11In Commercial Distribution
07350096320494PackageGS11In Commercial Distribution
07350096320531PackageGS11In Commercial Distribution
07350096320333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350096320340073500963203407350096320340
07350096320371073500963203717350096320371
07350096320456073500963204567350096320456
07350096320463073500963204637350096320463
07350096320470073500963204707350096320470
07350096320487073500963204877350096320487
07350096320494073500963204947350096320494
07350096320531073500963205317350096320531
07350096320333073500963203337350096320333

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
352736781
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350096320272Osseo 100+Osseo 100+ InstrumentY10041762024-10-30
07350096320234Osseo 100Osseo 100 SetY10041752022-03-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKX2026-09-24
06944843624365Ultrapro TX CordlessULTRADENT PRODUCTS, INC.EKX2026-09-19
08800313230017ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230024ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230031ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230048ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230055ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230062ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237429ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237436ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237443ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237450ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237467ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237474ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237481ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237498ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237504ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
06944843655932COLTENEGuilin Woodpecker Medical Instrument Co., Ltd.EKX2026-08-18
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06