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
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.NVK2026-08-03
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