FDA.reportPublic FDA data

EdgePro

Primary DI
08404535014655
Brand
EdgePro
Company
Peter Brasseler Holdings, LLC
Model
EDGEPRO-2
Catalog number
EDGEPRO-2
Device description
EDGEPRO COMPLETE SYSTEM
Published
2026-04-06
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
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
08404535014655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08404535014655084045350146558404535014655

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.

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919912125Brasseler USA5029292U05029292U02023-01-25
00887919752943Brasseler USA5025355U05025355U02026-07-27
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19
00887919711681Brasseler USA5024423U05024423U02026-06-19
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535030822Brasseler USA5032378U05032378U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27

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
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
00818365026456EdgePRO™US ENDODONTICS, LLCNVK2023-06-25
00818365026555EdgePRO™US ENDODONTICS, LLCNVK2023-06-25
00818365026661EdgePRO™US ENDODONTICS, LLCNVK2023-06-25