Jota

FDA UDI

Class I (US FDA UDI)

by Jota AG

Identity

Trade Name: JOTA FDA UDI
Generic Name: Diamond dental bur, reusable FDA UDI
Device Name: Diamonds FDA UDI
Model / Reference: 845.FG.010 FDA UDI
Description: Diamonds FDA UDI

Identifiers

Primary DI / UDI-DI: EJOT806314168524010 FDA UDI
FDA Product Code: DZP FDA UDI
GMDN Term: Diamond dental bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4535 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Diamond dental bur, reusable

Jota by Jota AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diamond dental bur, reusable.

Midwest Diamonds — Sirona Dental Systems GmbH · Class I
Sabur by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
MAXCUT DIAMOND BURS (6/pk) CRS 6852-012 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
Diatech Diamond Instruments — Coltène/Whaledent AG · Class I
HORICO — Hopf, Ringleb & Co. GmbH & Cie. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Jota AG

Sources (1)

FDA UDI 11a79746-6bff-4eb4-8c1e-9fe556c96c55 33 fields · synced May 30, 2026