FDA.reportPublic FDA data

Peezo Reamers, 1-6, 28

Primary DI
05060940375618
Brand
Peezo Reamers, 1-6, 28
Company
ENDOPERFECTION LIMITED
Model
ESP28AS
Published
2023-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05060940375618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060940375618050609403756185060940375618

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
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
05060940379401VaryFlex OS, VFOS, 20/07, 19mmVFOS2007192024-06-19
05060940376905VaryFlex Neo, 30/04, 25mmVFNEO3004252024-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630049902770Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990104Reamer 29mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990128Reamer 29mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990142Reamer 29mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990166Reamer 29mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990180Reamer 29mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990203Reamer 29mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990227Reamer 29mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990241Reamer 29mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990265Reamer 29mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990289Reamer 29mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990302Reamer 29mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990326Reamer 29mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990340Reamer 29mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990364Reamer 29mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996595Reamer 21mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996601Reamer 21mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996618Reamer 21mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996625Reamer 21mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996632Reamer 21mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996649Reamer 21mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996656Reamer 21mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996663Reamer 21mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996670Reamer 21mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996687Reamer 21mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996694Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996700Reamer 21mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996717Reamer 21mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996724Reamer 21mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996731Reamer 25mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02