FDA.reportPublic FDA data

Dento-Surg

Primary DI
00841494102517
Brand
Dento-Surg
Company
Cynosure, LLC
Model
DEN90110
Catalog number
DEN90110
Device description
DENTO-SURG 90 F.F.P. 110 VOLTS
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKZUNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKZUnit, Electrosurgical, And Accessories, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955176000DENTO-SURGEEllman Intl., Inc.1996-04-15EKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494102517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494102517008414941025178414941025170841494102517

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494100025Focus Cap Array100-7012-0552016-09-24
00841494100001PicoSure100-7012-0102016-09-24
00841494100056Elite MPX100-7009-0102016-09-24
00841494100063Elite+100-7018-0102016-09-24
00841494100070Apogee+100-7018-2902016-09-24
00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24
00841494106980PicoSure 532 Delivery System100-7012-5322017-07-24
00841494106997PicoSure 1064 Delivery System100-7012-1642017-07-24
00841494107246Refusrbished, Handpiece, 1064, PicoR100-7012-0792017-07-24
00841494107253Refusrbished, Handpiece, 532, PicoR100-7012-0762017-07-24
00841494104214PERF-GRIDEPG107EPG1072016-09-21
00841494104689SPLINT GRID NYLON MESH ROLLESG118ESG1182016-09-21
00841494104696SPLINT MESH STAINLESS STEEL MESH ROLLESG117ESG1172016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548213056545Root ZX3J.MORITA MFG.CORP.EKZ2023-06-27
00810000520046Sensimatic®PARKELL, INC.EKZ2021-12-10
00810000520107Sensimatic™PARKELL, INC.EKZ2021-12-10
04719873121281GT1 Blade Type ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121298GT2 Small Loop ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121304GT3 Large Loop ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121311GT4 Fine Wire ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121328GT5 Heavy Wire ElectrodeBONART CO., LTD.EKZ2020-02-27
04719873121335GT8 Heavy Ball Electrode (2.38mm)BONART CO., LTD.EKZ2020-02-27
04719873121342GT9 Heavy Ball Electrode (5mm)BONART CO., LTD.EKZ2020-02-27
00810000520749Sensimatic®PARKELL, INC.EKZ2020-02-07
00810000520718Sensimatic®PARKELL, INC.EKZ2019-08-16
04719873121250E1 Indiference Plate BONART CO., LTD.EKZ2019-02-28
04719873121267ART GT E1 Electrode SetBONART CO., LTD.EKZ2019-02-28
00810000520695Sensimatic®PARKELL, INC.EKZ2018-11-16
00810000520725Sensimatic®PARKELL, INC.EKZ2018-11-16
00810000520732Sensimatic®PARKELL, INC.EKZ2018-11-16
04719873121236E1 Handpiece (L)BONART CO., LTD.EKZ2018-11-05
04719873121243E1 Handpiece (S)BONART CO., LTD.EKZ2018-11-05
00853404007515MacanMacan ManufacturingEKZ2018-10-25
04719873121212E1 INDIFFERENCE PLATE ∮ 6.3mmBONART CO., LTD.EKZ2018-09-21
04719873121229METAL GROUNDING PLATE & CORDBONART CO., LTD.EKZ2018-09-21
00810000520763Sensimatic™PARKELL, INC.EKZ2018-09-21
00810000520770Sensimatic™PARKELL, INC.EKZ2018-09-21
00810000520701Sensimatic™PARKELL, INC.EKZ2018-09-14
00810000526710Parkell®PARKELL, INC.EKZ2018-09-14
00810000526727Parkell®PARKELL, INC.EKZ2018-09-14
00810000526734Parkell®PARKELL, INC.EKZ2018-09-14
00810000526741Parkell®PARKELL, INC.EKZ2018-09-14
00810000526758Parkell®PARKELL, INC.EKZ2018-09-14