FDA.reportPublic FDA data

Osstell Beacon Instrument

Primary DI
09010522000885
Brand
Osstell Beacon Instrument
Company
Osstell AB
Model
Osstell Osstell Beacon Instrument
Catalog number
103000
Device description
ISQ Measurement Instrument
Published
2022-09-02
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
K181888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181888000Osstell BeaconOsstell AB2019-08-22EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09010522000861PackageGS11In Commercial Distribution
09010522000878PackageGS11In Commercial Distribution
09010522000885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09010522000861090105220008619010522000861
09010522000878090105220008789010522000878
09010522000885090105220008859010522000885

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09010522002513SmartPeg Type 127SmartPeg Type 1271008102026-02-09
09010522002537SmartPeg Type 137SmartPeg Type 1371008112026-02-09
09010522002506SmartPeg Type 127SmartPeg Type 1271008102026-02-09
09010522002520SmartPeg Type 137SmartPeg Type 1371008112026-02-09
09010522002674MEGA ISQ II InstrumentOsstell MEGA ISQ II Instrument1031002025-09-26
09010522002650Osstell Beacon InstrumentOsstell Beacon Instrument1030002025-09-26
09010522002667MEGA ISQ II InstrumentOsstell MEGA ISQ II Instrument1031002025-09-26
09010522002636Osstell Classic InstrumentOsstell Classic Instrument080861482025-03-23
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
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
09010522000892Osstell IDx InstrumentOsstell Osstell IDx Instrument1010002022-11-01
09010522001097MEGA ISQ II InstrumentOsstell MEGA ISQ II Instrument1031002022-09-02
09010522001141DIO IDx InstrumentOsstell DIO IDx Instrument1005012022-11-01
09010522001189Osstell SmartPeg Type 03Osstell SmartPeg Type 031003572022-09-02
09010522001196Osstell SmartPeg Type 04Osstell SmartPeg Type 041003502022-09-02

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Primary DI, Brand, Company table
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