FDA.reportPublic FDA data

Gates Gliddens, 3, 28

Primary DI
05060940375434
Brand
Gates Gliddens, 3, 28
Company
ENDOPERFECTION LIMITED
Model
ESG283
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKPReamer, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKPReamer, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060940375434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060940375434050609403754345060940375434

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic enlarger, reusableA manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
224419290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060940379425VaryFlex Glide, VFG, 21mmVFG212025-06-19
05060940379432VaryFlex Glide, VFG, 31mmVFG312025-06-19
05060940379449VaryFlex Flow, VFF 21mm Size 45/04 VFF2145042025-06-19
05060940379456VaryFlex Flow, VFF 21mm Size 50/04 VFF2150042025-06-19
05060940379463VaryFlex Flow, VFF 25mm Size 45/04 VFF2545042025-06-19
05060940379470VaryFlex Flow, VFF 25mm Size 50/04 VFF2550042025-06-19
05060940379487VaryFlex Flow, VFF 31mm Size 45/04 VFF3145042025-06-19
05060940379494VaryFlex Flow, VFF 31mm Size 50/04 VFF3150042025-06-19
05060940379500VaryFlex Flow, VFF 21mm Size 45/06VFF2145062025-06-19
05060940379517VaryFlex Flow, VFF 21mm Size 50/06VFF2150062025-06-19
05060940379524VaryFlex Flow, VFF 25mm Size 45/06VFF2545062025-06-19
05060940379531VaryFlex Flow, VFF 25mm Size 50/06VFF2550062025-06-19
05060940379548VaryFlex Flow, VFF 31mm Size 45/06VFF3145062025-06-19
05060940379555VaryFlex Flow, VFF 31mm Size 50/06VFF3150062025-06-19
05060940379562VaryFlex Reciprocating, VFRF 50, 21mmVFRF21502025-06-19
05060940379579VaryFlex Reciprocating, VFRF 50, 25mmVFRF25502025-06-19
05060940379586VaryFlex Reciprocating, VFRF 50, 31mmVFRF31502025-06-19
05060940379418VaryFlex OR, VFOR, 20/07, 19mmVFOR2007192025-04-02
05060940376905VaryFlex Neo, 30/04, 25mmVFNEO3004252024-04-04
05060940376912VaryFlex Neo, 35/04, 25mmVFNEO3504252024-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D6620708732570PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708732650PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708732730PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708733800PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708733980PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708734060PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708736610PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708738770PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708738850PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708739430PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708739500PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708740810PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763180PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763260PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763340PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763420PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763750PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
05060940375786Lentulo, 25, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375793Lentulo, 30, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375809Lentulo, 35, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375816Lentulo, 40, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375823Lentulo, 25-40, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940379333Lentulo 25-40, 21ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375410Gates Gliddens, 1, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375427Gates Gliddens, 2, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375441Gates Gliddens, 4, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375458Gates Gliddens, 5, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375465Gates Gliddens, 6, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375472Gates Gliddens, 1-6, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375489Gates Gliddens, 1, 32ENDOPERFECTION LIMITEDEKP2023-12-11