FDA.reportPublic FDA data

Endo CSV

Primary DI
00766054002710
Brand
Endo CSV
Company
ESSENTIAL DENTAL SYSTEMS, INC.
Model
5100-00
Catalog number
5100-00
Device description
Endo CSV Hand Piece
Published
2020-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKXHandpiece, direct drive, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766054002710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766054002710007660540027107660540027100766054002710

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, battery-poweredA hand-held, electrically-powered dental device that includes a chuck or collet for attaching a rotary dental endpiece (e.g., polishing brush) intended to be used in dental procedures, typically for cleaning and polishing teeth. It is a battery-powered cordless instrument with an integral electric motor and push buttons for controlling the device settings; the endpiece(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(201)487-9090udi@edsdental.com

Regulatory Flags#

DUNS number
101147171
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766054002987Turbo-CR1100-301100-302025-04-04
00766054002994Turbo-CR1100-001100-002025-04-04
00766054003007Turbo-CR1100-1001100-1002025-04-04
00766054002949BIOSEAL1640-001640-002024-10-31
00766054002970BIOSEAL1640-151640-152024-10-31
00766054000341EDS Self Etch Bonding Agent900-00900-002017-02-01
00766054000693Tango-Endo5300-005300-002020-07-17
00766054001201Endo-Express5510-005510-002020-07-10
00766054001218Endo-Express5520-005520-002020-07-10
00766054002727Endo CSV5121-005121-002020-07-17
00766054002734Endo CSV5125-005125-002020-07-17
00766054002840Endo CSV5100-RH5100-RH2020-07-17
00766054000259EZ-Fill Bi-Directional Spiral1600-211600-212020-07-10
00766054000266EZ-Fill Bi-Directional Spiral1600-251600-252020-07-10
00766054000273EZ-Fill Bi-Directional Spiral1600-011600-012020-07-10
00766054000280EZ-Fill Bi-Directional Spiral1605-211605-212020-07-10
00766054000297EZ-Fill Bi-Directional Spiral1605-251605-252020-07-10
00766054000303EZ-Fill Bi-Directional Spiral1605-011605-012020-07-10
00766054001188Endo-Express5500-005500-002020-07-10
00766054001195Endo-Express5500TEP5500TEP2020-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858466005257ENDOMAXDENTAMERICA, INC.EKX2026-04-22
00858466005240ENDOMAXDENTAMERICA, INC.EKX2026-04-21
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0006X-Smart® Go Contra-angle (6:1)FORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0007X-Smart® Go Protective silicone sleeveFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100BSPXSGOAC0005X-Smart® Go Power bankFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
09010522002674MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518334InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
09010522002575Osstell SmartPeg Type 113Osstell ABEKX2025-03-27
09010522002599Osstell SmartPeg Type 114Osstell ABEKX2025-03-27
09010522002612Osstell SmartPeg Type 115Osstell ABEKX2025-03-27
09010522002483SmartPeg Type 117Osstell ABEKX2024-05-15