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Inion instrument

FDA UDI

Class II (US FDA UDI)

by Inion , Ltd.

Identity

Trade Name
Inion instrument FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Device Name
2.5 mm self tapping drill bit (Dental coupling) FDA UDI
Model / Reference
1 FDA UDI
Description
2.5 mm self tapping drill bit (Dental coupling) FDA UDI

Identifiers

Catalog Number
INS-9037 FDA UDI
Primary DI / UDI-DI
M224INS903710 FDA UDI
510(k) Number
K010352 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Inion instrument by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K010352 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inion , Ltd.

Sources (1)

  • FDA UDI a4ebfd06-eb6e-4806-8c50-5966dc2d095d 36 fields · synced Jun 8, 2026