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Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
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Review Panel
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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
DZJ
Driver, Wire, And Bone Drill, Manual
2
Product Code
DZK
Wire, Fixation, Intraosseous
2
Product Code
DZL
Screw, Fixation, Intraosseous
2
Product Code
DZM
Needle, Dental
1
Product Code
DZN
Instruments, Dental Hand
1
Product Code
DZP
Instrument, Diamond, Dental
1
Product Code
DYX
Lock, Wire, And Ligature, Intraoral
2
Product Code
DZA
Drill, Dental, Intraoral
1
Product Code
DZH
Saw, Bone, Ac-Powered
2
Product Code
DZI
Drill, Bone, Powered
2
Product Code
EAX
Mirror, Mouth
1
Product Code
EAY
Light, Fiber Optic, Dental
1
Product Code
EAZ
Light, Operating, Dental
1
Product Code
EBA
Light, Surgical Headlight
1
Product Code
EBW
Controller, Foot, Handpiece And Cord
1
Product Code
ECB
Unit, Syringe, Air And/Or Water
1
Product Code
ECP
Instrument, Ligature Tucking, Orthodontic
1
Product Code
ECQ
Aligner, Bracket, Orthodontic
1
Product Code
ECR
Setter, Band, Orthodontic
1
Product Code
ECS
Pusher, Band, Orthodontic
1
Product Code
ECT
Driver, Band, Orthodontic
1
Product Code
EFA
Handpiece, Belt And/Or Gear Driven, Dental
1
Product Code
EFB
Handpiece, Air-Powered, Dental
1
Product Code
EFK
Forceps, Articulation Paper
1
Product Code
EFL
Forceps, Dressing, Dental
1
Product Code
EGI
Parallelometer
1
Product Code
EGM
Injector, Jet, Mechanical-Powered
2
Product Code
EGN
Scissors, Surgical Tissue, Dental
1
Product Code
EGQ
Injector, Jet, Gas-Powered
2
Product Code
EGS
Handpiece, Contra- And Right-Angle Attachment, Dental
1
Product Code
EIB
Syringe, Irrigating (Dental)
1
Product Code
EIC
Syringe, Periodontic, Endodontic, Irrigating
1
Product Code
EID
Syringe, Restorative And Impression Material
1
Product Code
EIF
Accessories, Retractor, Dental
1
Product Code
EIG
Retractor, All Types
1
Product Code
EIK
Carver, Wax, Dental
1
Product Code
EIL
Gauge, Depth, Instrument, Dental
1
Product Code
EIR
Scissors, Collar And Crown
1
Product Code
EIS
Remover, Crown
1
Product Code
EIX
Probe, Periodontic
1
Product Code
EIY
Instrument, Filling, Plastic, Dental
1
Product Code
EJB
Handle, Instrument, Dental
1
Product Code
EJY
Pliers, Operative
1
Product Code
EJZ
Knife, Margin Finishing, Operative
1
Product Code
EKA
File, Margin Finishing, Operative
1
Product Code
EKB
Explorer, Operative
1
Product Code
EKC
Excavator, Dental, Operative
1
Product Code
EKD
Instrument, Cutting, Operative
1
Product Code
EKE
Curette, Operative
1
Product Code
EKF
Instrument, Contouring, Matrix, Operative
1
Product Code
EKG
Condenser, Amalgam And Foil, Operative
1
Product Code
EKH
Carver, Dental Amalgam, Operative
1
Product Code
EKI
Carrier, Amalgam, Operative
1
Product Code
EKJ
Burnisher, Operative
1
Product Code
EKK
Spreader, Pulp Canal Filling Material, Endodontic
1
Product Code
EKP
Reamer, Pulp Canal, Endodontic
1
Product Code
EKQ
Preparer, Root Canal Endodontic
1
Product Code
EKR
Plugger, Root Canal, Endodontic
1
Product Code
EKS
File, Pulp Canal, Endodontic
1
Product Code
EKT
Curette, Endodontic
1
Product Code
EKW
Broach, Endodontic
1
Product Code
EKX
Handpiece, Direct Drive, Ac-Powered
1
Product Code
EKY
Handpiece, Water-Powered
1
Product Code
EKZ
Unit, Electrosurgical, And Accessories, Dental
2
Product Code
ELA
Instrument, Hand, Calculus Removal
1
Product Code
ELB
Scaler, Rotary
2
Product Code
ELC
Scaler, Ultrasonic
2
Product Code
EMD
Hemostat, Surgical
1
Product Code
EME
Punch, Biopsy, Surgical
1
Product Code
EMG
Forceps, Tooth Extractor, Surgical
1
Product Code
EMH
Forceps, Rongeur, Surgical
1
Product Code
EMI
File, Bone, Surgical
1
Product Code
EMJ
Elevator, Surgical, Dental
1
Product Code
EMK
Curette, Surgical, Dental
1
Product Code
EML
Chisel, Bone, Surgical
1
Product Code
EMM
Chisel, Osteotome, Surgical
1
Product Code
EMN
Scaler, Periodontic
1
Product Code
EMO
Knife, Periodontic
1
Product Code
EMP
Marker, Periodontic
1
Product Code
EMQ
Hoe, Periodontic
1
Product Code
EMR
File, Periodontic
1
Product Code
EMS
Curette, Periodontic
1
Product Code
JEP
Retainer, Matrix
1
Product Code
JEX
Plier, Orthodontic
1
Product Code
JEY
Plate, Bone
2
Product Code
KMW
Handpiece, Rotary Bone Cutting
2
Product Code
MDL
Implant, Transmandibular
2
Product Code
MQN
External Mandibular Fixator And/Or Distractor
2
Product Code
MXF
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
2
Product Code
NEI
Prosthesis, Condyle, Mandibular, Temporary
2
Product Code
NLD
Instrument, Diamond, Dental, Reprocessed
1
Product Code
NMW
Needle, Dental, Reprocessed
1
Product Code
NYC
Dental Prophylaxis Kit
1
Product Code
NYF
Gingival Retraction Kit
1
Product Code
NYG
Lapping Tool Kit
1
Product Code
NYL
Handpiece, Air-Powered, Root Canal Irrigation
1
Product Code
PLV
Dental Stereotaxic Instrument
2
Product Code
PWL
Oral Surgery Tray
1
Product Code
NVK
Laser, Dental, Soft Tissue
2
Product Code
K
23
0047
Medical Diode Laser Systems
2
Cleared 510(K)
K
23
2885
Dawn Diode Laser System
2
Cleared 510(K)
K
23
2222
Primo Dental Laser
2
Cleared 510(K)
K
22
1761
Solea
2
Cleared 510(K)
K
21
1150
Dental diode laser, SOGA Laser, ILaser II
2
Cleared 510(K)
K
21
4008
Dental diode laser
2
Cleared 510(K)
K
21
3658
DEKA SMARTPERIO
2
Cleared 510(K)
K
21
0367
D-Laser Blue, D-Laser 16
2
Cleared 510(K)
K
21
3428
EdgePro
2
Cleared 510(K)
K
21
0350
Gemini 2 810+980 Soft Tissue Laser
2
Cleared 510(K)
Show All 13 Submissions
OAJ
Catheter, Drainage, Intraoral/Extraoral
1
Product Code
PEM
Dental Barriers And Sleeves
2
Product Code
QRY
Dental Navigation System
2
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
DE
/
subpart-e—surgical-devices
/
NVK
/
K232222
View Source
Primo Dental Laser
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232222
510(k) Type
Traditional
Applicant
Medency S.r.l.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
11/27/2023
Days to Decision
124 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
DZJ
Driver, Wire, And Bone Drill, Manual
DZK
Wire, Fixation, Intraosseous
DZL
Screw, Fixation, Intraosseous
DZM
Needle, Dental
DZN
Instruments, Dental Hand
DZP
Instrument, Diamond, Dental
DYX
Lock, Wire, And Ligature, Intraoral
DZA
Drill, Dental, Intraoral
DZH
Saw, Bone, Ac-Powered
DZI
Drill, Bone, Powered
EAX
Mirror, Mouth
EAY
Light, Fiber Optic, Dental
EAZ
Light, Operating, Dental
EBA
Light, Surgical Headlight
EBW
Controller, Foot, Handpiece And Cord
ECB
Unit, Syringe, Air And/Or Water
ECP
Instrument, Ligature Tucking, Orthodontic
ECQ
Aligner, Bracket, Orthodontic
ECR
Setter, Band, Orthodontic
ECS
Pusher, Band, Orthodontic
ECT
Driver, Band, Orthodontic
EFA
Handpiece, Belt And/Or Gear Driven, Dental
EFB
Handpiece, Air-Powered, Dental
EFK
Forceps, Articulation Paper
EFL
Forceps, Dressing, Dental
EGI
Parallelometer
EGM
Injector, Jet, Mechanical-Powered
EGN
Scissors, Surgical Tissue, Dental
EGQ
Injector, Jet, Gas-Powered
EGS
Handpiece, Contra- And Right-Angle Attachment, Dental
EIB
Syringe, Irrigating (Dental)
EIC
Syringe, Periodontic, Endodontic, Irrigating
EID
Syringe, Restorative And Impression Material
EIF
Accessories, Retractor, Dental
EIG
Retractor, All Types
EIK
Carver, Wax, Dental
EIL
Gauge, Depth, Instrument, Dental
EIR
Scissors, Collar And Crown
EIS
Remover, Crown
EIX
Probe, Periodontic
EIY
Instrument, Filling, Plastic, Dental
EJB
Handle, Instrument, Dental
EJY
Pliers, Operative
EJZ
Knife, Margin Finishing, Operative
EKA
File, Margin Finishing, Operative
EKB
Explorer, Operative
EKC
Excavator, Dental, Operative
EKD
Instrument, Cutting, Operative
EKE
Curette, Operative
EKF
Instrument, Contouring, Matrix, Operative
EKG
Condenser, Amalgam And Foil, Operative
EKH
Carver, Dental Amalgam, Operative
EKI
Carrier, Amalgam, Operative
EKJ
Burnisher, Operative
EKK
Spreader, Pulp Canal Filling Material, Endodontic
EKP
Reamer, Pulp Canal, Endodontic
EKQ
Preparer, Root Canal Endodontic
EKR
Plugger, Root Canal, Endodontic
EKS
File, Pulp Canal, Endodontic
EKT
Curette, Endodontic
EKW
Broach, Endodontic
EKX
Handpiece, Direct Drive, Ac-Powered
EKY
Handpiece, Water-Powered
EKZ
Unit, Electrosurgical, And Accessories, Dental
ELA
Instrument, Hand, Calculus Removal
ELB
Scaler, Rotary
ELC
Scaler, Ultrasonic
EMD
Hemostat, Surgical
EME
Punch, Biopsy, Surgical
EMG
Forceps, Tooth Extractor, Surgical
EMH
Forceps, Rongeur, Surgical
EMI
File, Bone, Surgical
EMJ
Elevator, Surgical, Dental
EMK
Curette, Surgical, Dental
EML
Chisel, Bone, Surgical
EMM
Chisel, Osteotome, Surgical
EMN
Scaler, Periodontic
EMO
Knife, Periodontic
EMP
Marker, Periodontic
EMQ
Hoe, Periodontic
EMR
File, Periodontic
EMS
Curette, Periodontic
JEP
Retainer, Matrix
JEX
Plier, Orthodontic
JEY
Plate, Bone
KMW
Handpiece, Rotary Bone Cutting
MDL
Implant, Transmandibular
MQN
External Mandibular Fixator And/Or Distractor
MXF
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
NEI
Prosthesis, Condyle, Mandibular, Temporary
NLD
Instrument, Diamond, Dental, Reprocessed
NMW
Needle, Dental, Reprocessed
NYC
Dental Prophylaxis Kit
NYF
Gingival Retraction Kit
NYG
Lapping Tool Kit
NYL
Handpiece, Air-Powered, Root Canal Irrigation
PLV
Dental Stereotaxic Instrument
PWL
Oral Surgery Tray
NVK
Laser, Dental, Soft Tissue
K
23
0047
Medical Diode Laser Systems
K
23
2885
Dawn Diode Laser System
K
23
2222
Primo Dental Laser
K
22
1761
Solea
K
21
1150
Dental diode laser, SOGA Laser, ILaser II
K
21
4008
Dental diode laser
K
21
3658
DEKA SMARTPERIO
K
21
0367
D-Laser Blue, D-Laser 16
K
21
3428
EdgePro
K
21
0350
Gemini 2 810+980 Soft Tissue Laser
Show All 13 Submissions
OAJ
Catheter, Drainage, Intraoral/Extraoral
PEM
Dental Barriers And Sleeves
QRY
Dental Navigation System
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
DE
/
subpart-e—surgical-devices
/
NVK
/
K232222
View Source
Primo Dental Laser
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232222
510(k) Type
Traditional
Applicant
Medency S.r.l.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
11/27/2023
Days to Decision
124 days
Submission Type
Summary