FDA.reportPublic FDA data

Osstell Beacon Instrument

Primary DI
09010522002650
Brand
Osstell Beacon Instrument
Company
Osstell AB
Model
Osstell Beacon Instrument
Catalog number
103000
Device description
ISQ Measurement Instrument
Published
2025-09-26
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09010522002643PackageGS11In Commercial Distribution
09010522002650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09010522002643090105220026439010522002643
09010522002650090105220026509010522002650

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant stability resonance frequency analysis unitAn electrically-powered device designed to measure the stability of a dental implant by creating a noninvasive vibrational force and subsequently detecting the amount of movement in the implant [typically referred to as resonance frequency analysis (RFA)]. It is used with a disposable peg (not included) inserted into the implant or abutment, and consists of electronics to create an electromagnetic pulsation to vibrate the peg, a monitor, controls and a probe. This measurement can be repeated over time to assess the progress of implant osseointegration. It may be supplied with accessories such as mounts and test pegs.

Regulatory Flags#

DUNS number
633171269
Device count
1
DM exempt
true
Premarket exempt
false
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
09010522003015Osstell SmartPeg Type 116Osstell SmartPeg Type 116080861532026-08-30
09010522003022Osstell SmartPeg Type 118Osstell SmartPeg Type 118080861542026-08-30
09010522003039Osstell SmartPeg Type 119Osstell SmartPeg Type 119080861552026-08-30
09010522003046Osstell SmartPeg Type 120Osstell SmartPeg Type 120080861562026-08-30
09010522003053Osstell SmartPeg Type 121Osstell SmartPeg Type 121080861572026-08-30
09010522003060Osstell SmartPeg Type 122Osstell SmartPeg Type 122080861582026-08-30
09010522003077Osstell SmartPeg Type 123Osstell SmartPeg Type 123080861592026-08-30
09010522000885Osstell Beacon InstrumentOsstell Osstell Beacon Instrument1030002022-09-02
09010522002094Osstell SmartPeg Type 99Osstell SmartPeg Type 991007642023-11-01
09010522002414SmartPeg Type 18 - NeossSmartPeg Type 18 - Neoss910702023-11-01
09010522002421SmartPeg Type 38 - NeossSmartPeg Type 38 - Neoss910712023-11-01
09010522002438SmartPeg Type 52 - NeossSmartPeg Type 52 - Neoss910722023-11-01
09010522002513SmartPeg Type 127SmartPeg Type 1271008102026-02-09
09010522002537SmartPeg Type 137SmartPeg Type 1371008112026-02-09
09010522002575Osstell SmartPeg Type 113Osstell SmartPeg Type 113080861452025-03-27
09010522002599Osstell SmartPeg Type 114Osstell SmartPeg Type 114080861462025-03-27
09010522002612Osstell SmartPeg Type 115Osstell SmartPeg Type 115080861472025-03-27
09010522002674MEGA ISQ II InstrumentOsstell MEGA ISQ II Instrument1031002025-09-26
09010522002551Osstell SmartPeg Type 112Osstell SmartPeg Type 112080861442025-03-27
09010522002636Osstell Classic InstrumentOsstell Classic Instrument080861482025-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313237511ChecQPEGDENTIS CO. ,LTDEKX2026-09-29
08800313237528ChecQPEGDENTIS CO. ,LTDEKX2026-09-29
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
09010522003015Osstell SmartPeg Type 116Osstell ABEKX2026-08-30
09010522003022Osstell SmartPeg Type 118Osstell ABEKX2026-08-30
09010522003039Osstell SmartPeg Type 119Osstell ABEKX2026-08-30
09010522003046Osstell SmartPeg Type 120Osstell ABEKX2026-08-30
09010522003053Osstell SmartPeg Type 121Osstell ABEKX2026-08-30
09010522003060Osstell SmartPeg Type 122Osstell ABEKX2026-08-30
09010522003077Osstell SmartPeg Type 123Osstell ABEKX2026-08-30
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