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
00887919956815LARGE BONE BLADESSAW6944TSAW6944T2026-10-27
00887919956846LARGE BONE BLADESSAW6945TSAW6945T2026-10-27
00887919956877LARGE BONE BLADESSAW6946TSAW6946T2026-10-27
00887919956969LARGE BONE BLADESSAW6949TSAW6949T2026-10-27
00887919956990LARGE BONE BLADESSAW6950TSAW6950T2026-10-27
00887919957027LARGE BONE BLADESSAW6951TSAW6951T2026-10-27
00887919956907LARGE BONE BLADESSAW6947TSAW6947T2026-10-26
00887919956938LARGE BONE BLADESSAW6948TSAW6948T2026-10-26
08404535025309Brasseler USA5032037U05032037U02026-04-29
00887919673880Brasseler USA5022563U05022563U02023-01-25
00887919676218Brasseler USA5022790U05022790U02023-01-25
00887919676232Brasseler USA5022792U05022792U02023-01-25
00887919676249Brasseler USA5022793U05022793U02023-01-25
00887919810926Brasseler USA5026807U05026807U02023-01-25
08404535020779Brasseler USA5031841U05031841U02026-10-20
08404535020809Brasseler USA5031842U05031842U02026-10-20
08404535037654Brasseler USA5032402U05032402U02026-10-20
08404535037685Brasseler USA5032403U05032403U02026-10-20
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28

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