FDA.reportPublic FDA data

Osstell SmartPeg Type 94

Primary DI
09010522001042
Brand
Osstell SmartPeg Type 94
Company
Osstell AB
Model
Osstell SmartPeg Type 94
Catalog number
100757
Device description
ISQ Measurement Peg
Published
2022-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09010522001042PackageGS15In Commercial Distribution
09010522002001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09010522001042090105220010429010522001042
09010522002001090105220020019010522002001

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant stability measurement pegA small, sterile, screw-like device intended to be attached to a dental implant or abutment to measure the stability of the implant. It is used with a control unit (not included) which provides an electromagnetic pulsation to create a noninvasive vibrating force in the peg, and the subsequent degree of peg movement provides a measure of dental implant stability. This measurement can be repeated over time to help assess the progress of implant osseointegration. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
633171269
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
false
Expiration date on label
true
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
09010522002506SmartPeg Type 127SmartPeg Type 1271008102026-02-09
09010522002520SmartPeg Type 137SmartPeg Type 1371008112026-02-09
09010522002650Osstell Beacon InstrumentOsstell Beacon Instrument1030002025-09-26
09010522002667MEGA ISQ II InstrumentOsstell MEGA ISQ II Instrument1031002025-09-26
09010522002551Osstell SmartPeg Type 112Osstell SmartPeg Type 112080861442025-03-27
09010522002568Osstell SmartPeg Type 113Osstell SmartPeg Type 113080861452025-03-27
09010522002582Osstell SmartPeg Type 114Osstell SmartPeg Type 114080861462025-03-27
09010522002605Osstell SmartPeg Type 115Osstell SmartPeg Type 115080861472025-03-27
09010522002636Osstell Classic InstrumentOsstell Classic InstrumentR80861482025-03-23
09010522000731Osstell ISQ ProbeOsstell ISQ Probe1005012022-11-01
09010522002315Osstell SmartPeg Type 110Osstell SmartPeg Type 1102022-11-01
09010522002322Osstell SmartPeg Type 111Osstell SmartPeg Type 1111007712022-11-01
09010522000847Osstell IDx InstrumentOsstell Osstell IDx Instrument1010002022-11-01
09010522001134DIO IDx InstrumentOsstell DIO IDx Instrument1005012022-11-01
09010522002476SmartPeg Type 117SmartPeg Type 1171008092024-05-15
09010522002070SmartPeg Type 98 - NeossSmartPeg Type 98 - Neoss910732024-05-14
09010522002469Neoss SmartPeg MountNeoss SmartPeg Mount910752023-12-06
09010522002087Osstell SmartPeg Type 99Osstell SmartPeg Type 991007642023-11-01
09010522002117Osstell SmartPeg Type 100Osstell SmartPeg Type 1001007652023-11-01
09010522002131Osstell SmartPeg Type 101Osstell SmartPeg Type 1011007662023-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313230000ChecQPEGDENTIS CO. ,LTDEKX2026-03-03
10194665008444A-decA-DEC, INC.EKX2026-02-19
E27668665320Midwest IMPLANT 20:1SIRONA Dental Systems GmbHEKX2026-02-19
09010522002506SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002520SmartPeg Type 137Osstell ABEKX2026-02-09
06941877827809ZarcChangzhou Sifary Medical Technology Co., Ltd.EKX2026-01-05
06944835130195NIC/SUPERLINEShenzhen Superline Technology Co., Ltd.EKX2025-12-22
10817417020395AsepticoASEPTICO, INC.EKX2025-12-16
10817417020401AsepticoASEPTICO, INC.EKX2025-12-16
08056814270117EnDrive ADVANCED TECHNOLOGY RESEARCH A.T.R. SRLEKX2025-11-26
09010522002650Osstell Beacon InstrumentOsstell ABEKX2025-09-26
09010522002667MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518327InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
08809455602683elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602720elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602744elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08800053084123ChecQDENTIS CO. ,LTDEKX2025-03-31
08800053092494ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092500ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092517ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092524ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092531ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092548ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092555ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092562ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092579ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092586ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092593ChecQPEG DriverDENTIS CO. ,LTDEKX2025-03-31
08800266943897ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
09010522002551Osstell SmartPeg Type 112Osstell ABEKX2025-03-27