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
New
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
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.

Sterilization Methods#

Method table
Method

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
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
09010522000885Osstell Beacon InstrumentOsstell Osstell Beacon Instrument1030002022-09-02
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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