FDA.reportPublic FDA data

RISPI SONIC

Primary DI
J015201170029
Brand
RISPI SONIC
Company
MICRO MEGA
Model
n0 L22
Catalog number
20117002
Device description
Endodontic instrument for professionnal dental use only
Published
2020-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EKWBroach, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKWBroach, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J015201170029PackageHIBCC10In Commercial Distribution
J015201170021PrimaryHIBCC0
J015201170020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic broach, serrated, reusableA hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
276075371
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
J015600406651MM K-Filesn006 L21 ISO M09600406652026-04-08
J015600406661MM K-Filesn008 L21 ISO M09600406662026-04-08
J015600406671MM K-Filesn010 L21 ISO M09600406672026-04-08
J015600406681MM K-Filesn015 L21 ISO M09600406682026-04-08
J015600406691MM K-Filesn020 L21 ISO M09600406692026-04-08
J015600406701MM K-Filesn025 L21 ISO M09600406702026-04-08
J015600406711MM K-Filesn030 L21 ISO M09600406712026-04-08
J015600406721MM K-Filesn035 L21 ISO M09600406722026-04-08
J015600406731MM K-Filesn040 L21 ISO M09600406732026-04-08
J015600406741MM K-Filesn045 L21 ISO M09600406742026-04-08
J015600406751MM K-Filesn050 L21 ISO M09600406752026-04-08
J015600406761MM K-Filesn055 L21 ISO M09600406762026-04-08
J015600406771MM K-Filesn060 L21 ISO M09600406772026-04-08
J015600406781MM K-Filesn070 L21 ISO M09600406782026-04-08
J015600406791MM K-Filesn080 L21 ISO M09600406792026-04-08
J015600406821MM K-Filesn006 L25 ISO M09600406822026-04-08
J015600406831MM K-Filesn008 L25 ISO M09600406832026-04-08
J015600406841MM K-Filesn010 L25 ISO M09600406842026-04-08
J015600406851MM K-Filesn015 L25 ISO M09600406852026-04-08
J015600406861MM K-Filesn020 L25 ISO M09600406862026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D6620708761021PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761101PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761281PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761361PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761441PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761511PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761691PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761020PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761100PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761280PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761360PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761440PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761510PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761690PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
05060940375236Barbed Broaches, 0, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375243Barbed Broaches, 1, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375250Barbed Broaches, 2, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375267Barbed Broaches, 3, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375274Barbed Broaches, 4, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375281Barbed Broaches, 5, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375298Barbed Broaches, 6, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375304Barbed Broaches, 2-4, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375311Barbed Broaches, 0-6, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375328Barbed Broaches, 0, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375335Barbed Broaches, 1, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375342Barbed Broaches, 2, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375359Barbed Broaches, 3, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375366Barbed Broaches, 4, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375373Barbed Broaches, 5, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375380Barbed Broaches, 6, 25ENDOPERFECTION LIMITEDEKW2023-12-12