FDA.report

JOTA

Primary DI
EJOT685204243512030
Brand
JOTA
Company
Jota AG
Model
9122F.RA.030
Device description
Polishers
Published
2023-09-28
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
EJQWheel, Polishing Agent

Product Code Classifications

CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EJOT685204243512030PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental polishing brushA rotational device, typically composed of a metal shaft with bristles containing silicium carbide material, that is used for the quick grinding and polishing of dental composite materials and hard dental tissues to produce a high shine. It is held in a dental handpiece, which rotates the brush at high speeds [e.g., 5000 revolutions per minute (rpm)]. It is suitable for interproximal areas and occlusal surfaces. 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
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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
07630243636051KENDADent4You AGEJQ2025-09-17
07630243636075KENDADent4You AGEJQ2025-09-17
07630243636082KENDADent4You AGEJQ2025-09-17
07630243636105KENDADent4You AGEJQ2025-09-17
07630243636112KENDADent4You AGEJQ2025-09-17
07630243636099KENDADent4You AGEJQ2025-09-17
07630243641406KENDADent4You AGEJQ2025-09-17
07630243641413KENDADent4You AGEJQ2025-09-17
07630243636068KENDADent4You AGEJQ2025-09-17
07630243636228KENDADent4You AGEJQ2025-09-17
07630243636235KENDADent4You AGEJQ2025-09-17
07630243636242KENDADent4You AGEJQ2025-09-17
07630243636259KENDADent4You AGEJQ2025-09-17
07630243636273KENDADent4You AGEJQ2025-09-17
07630243636280KENDADent4You AGEJQ2025-09-17
07630243636266KENDADent4You AGEJQ2025-09-17
07630243641727KENDADent4You AGEJQ2025-09-17
07630243637225KENDADent4You AGEJQ2025-09-17
07630243637232KENDADent4You AGEJQ2025-09-17
07630243637249KENDADent4You AGEJQ2025-09-17
07630243637256KENDADent4You AGEJQ2025-09-17
07630243637362KENDADent4You AGEJQ2025-09-17
07630243637379KENDADent4You AGEJQ2025-09-17
07630243637386KENDADent4You AGEJQ2025-09-17
07630243637393KENDADent4You AGEJQ2025-09-17
07630243642052KENDADent4You AGEJQ2025-09-17
07630243642069KENDADent4You AGEJQ2025-09-17
07630243636709KENDADent4You AGEJQ2025-09-17
07630243636716KENDADent4You AGEJQ2025-09-17
07630243636730KENDADent4You AGEJQ2025-09-17