FDA.reportPublic FDA data

StarDental Instrument Solutions

Primary DI
D7022656770
Brand
StarDental Instrument Solutions
Company
DENTALEZ, INC.
Model
265677
Device description
STARBRIGHT SINGLE LAMP CONTROL SYSTEM
Published
2018-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944271000DENTAL OPERATIVE UNIT ACCESORIESDci Intl.1994-12-29EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7022656770PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device light source controllerA mains electricity (AC-powered) device intended to step down the electrical power from the mains to supply power to and provide control of (e.g., on/off) a light source associated with another medical device (e.g. surgical power tool). This controller may be operated through hand and/or foot controls. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-866-383-4636xx@xx.xx

Regulatory Flags#

DUNS number
059010363
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7022666500StarDental2666502666502026-04-22
D7022666510StarDental2666512666512026-04-22
D7022666520StarDental2666522666522026-04-22
D7022666530StarDental2666532666532026-04-22
D7022663420StarDental2663422663422025-06-20
D7022663430StarDental2663432025-06-20
D7022663450StarDental2663452025-06-20
D7022664900StarDental2664902025-06-20
D7022601520StarDental Instrument Solutions2601522018-11-05
D702RT3001050StarDental Instrument SolutionsRT3-001052016-09-13
D7022656330StarDental Instrument Solutions2656332018-11-05
D7022639480StarDental Instrument Solutions2639482018-11-05
D7022658060StarDental Instrument Solutions2658062018-11-05
D702RT3001130StarDental Instrument SolutionsRT3-001132016-09-12
D702RT3220000StarDental Instrument SolutionsRT3-220002016-09-12
D7022688600StarDental Instrument Solutions2688602018-11-05
D7022656300StarDental Instrument Solutions2656302018-11-05
D7022656340StarDental Instrument Solutions2656342018-11-05
D7022658210StarDental Instrument Solutions2658212018-11-05
D7022658220StarDental Instrument Solutions2658222018-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
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J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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