FDA.report

JOTA

Primary DI
EJOT1325
Brand
JOTA
Company
Jota AG
Model
1325
Published
2025-06-12
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
false

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EJOT1325PrimaryHIBCC0

GMDN Terms

TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
480670983
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
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 DIBrandModelCatalogPublished
EJOT022204034491070JOTA9997M.RA.0702025-06-25
EJOT1330JOTA13302025-06-25
EJOT1331JOTA13312025-06-25
EJOT1366JOTA13662025-06-25
EJOT1391JOTA13912025-06-25
EJOT1393JOTA13932025-06-25
EJOT1395JOTA13952025-06-25
EJOT1396JOTA13962025-06-25
EJOT1399JOTA13992025-06-25
EJOT1414JOTA14142025-06-25
EJOT1430JOTA14302025-06-25
EJOT1432JOTA14322025-06-25
EJOT1435JOTA14352025-06-25
EJOT1436JOTA14362025-06-25
EJOT1439JOTA14392025-06-25
EJOT1453JOTA14532025-06-25
EJOT1454JOTA14542025-06-25
EJOT1456JOTA14562025-06-25
EJOT1457JOTA14572025-06-25
EJOT1458JOTA14582025-06-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810126508270Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508324Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
07908738731940DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730585DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
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