FDA.reportPublic FDA data

EdgePRO™

Primary DI
00818365026456
Brand
EdgePRO™
Company
US ENDODONTICS, LLC
Model
6400463
Catalog number
6400463
Device description
EdgePRO™ AAA Footswitch Batteries (2-Pack)
Published
2023-06-25
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
NVKLaser, dental, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVKLaser, Dental, Soft TissueGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213428000EdgeProBiolase, Inc.2021-12-22NVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818365026456PrimaryGS10
10818365026453Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365026456008183650264568183650264560818365026456
1081836502645310818365026453

GMDN Terms#

Term, Definition table
TermDefinition
Dental solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.

Contacts#

Phone, Email table
PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags#

DUNS number
061317427
Device count
2
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810047645351EdgeSequel UtopiaES150421SEES150421SE2023-07-28
00810047645368EdgeSequel UtopiaES150425SEES150425SE2023-07-28
00810047645375EdgeSequel UtopiaES150431SEES150431SE2023-07-28
00810047645382EdgeSequel UtopiaES250421SEES250421SE2023-07-28
00810047645399EdgeSequel UtopiaES250425SEES250425SE2023-07-28
00810047645405EdgeSequel UtopiaES250431SEES250431SE2023-07-28
00810047645412EdgeSequel UtopiaES300421SEES300421SE2023-07-28
00810047645429EdgeSequel UtopiaES300425SEES300425SE2023-07-28
00810047645436EdgeSequel UtopiaES300431SEES300431SE2023-07-28
00810047645443EdgeSequel UtopiaES400421SEES400421SE2023-07-28
00810047645450EdgeSequel UtopiaES400425SEES400425SE2023-07-28
00810047645467EdgeSequel UtopiaES400431SEES400431SE2023-07-28
00810047645474EdgeSequel UtopiaES500421SEES500421SE2023-07-28
00810047645481EdgeSequel UtopiaES500425SEES500425SE2023-07-28
00810047645498EdgeSequel UtopiaES500431SEES500431SE2023-07-28
00810047645504EdgeSequel UtopiaES250621SEES250621SE2023-07-28
00810047645511EdgeSequel UtopiaES250625SEES250625SE2023-07-28
00810047645528EdgeSequel UtopiaES250631SEES250631SE2023-07-28
00810047645535EdgeSequel UtopiaES300621SEES300621SE2023-07-28
00810047645542EdgeSequel UtopiaES300625SEES300625SE2023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944843604473DTEGuilin Woodpecker Medical Instrument Co., Ltd.NVK2026-04-15
06944843604480DTEGuilin Woodpecker Medical Instrument Co., Ltd.NVK2026-04-15
06944843617169WOODPECKERGuilin Woodpecker Medical Instrument Co., Ltd.NVK2026-04-15
06944843617176WOODPECKERGuilin Woodpecker Medical Instrument Co., Ltd.NVK2026-04-15
00872320006440Picasso Pro Diode LaserCAO GROUP, INC.NVK2026-04-10
00872320006617Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.NVK2026-04-10
00872320006846LEAP Laser Delivery TipCAO GROUP, INC.NVK2026-04-10
00872320006853Picasso Pro Pre-initiated Laser Tip, 300um, 5mmCAO GROUP, INC.NVK2026-04-10
00872320006860Picasso Pro Pre-initiated Laser Tip, 300um, 10mmCAO GROUP, INC.NVK2026-04-10
00872320006877Picasso Pro Pre-initiated Laser Tip, 400um, 5mmCAO GROUP, INC.NVK2026-04-10
00872320006884Picasso Pro Pre-initiated Laser Tip, 400um, 10mmCAO GROUP, INC.NVK2026-04-10
00872320006891Picasso Pro Disposable Therapy Tip, StraightCAO GROUP, INC.NVK2026-04-10
00872320006907Picasso Pro Disposable Therapy Tip, CurvedCAO GROUP, INC.NVK2026-04-10
08404535014655EdgeProPeter Brasseler Holdings, LLCNVK2026-04-06
06974624062116PIOONWuhan Pioon Technology Co., Ltd.NVK2025-07-08
06974624062109PIOONWuhan Pioon Technology Co., Ltd.NVK2025-07-07
06977331780007GIGAAGigaalaser Company Ltd.NVK2024-11-30
06977331780014GIGAAGigaalaser Company Ltd.NVK2024-11-01
06977331780021GIGAAGigaalaser Company Ltd.NVK2024-11-01
06977331780038GIGAAGigaalaser Company Ltd.NVK2024-11-01
08059340290000Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290017Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290024Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290031Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290048Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290055Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290062Primo Dental LaserMEDENCY SRLNVK2024-04-10
08059340290079Primo Dental LaserMEDENCY SRLNVK2024-04-10
00818365026555EdgePRO™US ENDODONTICS, LLCNVK2023-06-25
00818365026661EdgePRO™US ENDODONTICS, LLCNVK2023-06-25