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Imtec

FDA UDI

Class I (US FDA UDI)

by Park Dental Research Corp

Identity

Trade Name
IMTEC FDA UDI
Generic Name
Fluted surgical drill bit, single-use FDA UDI
Device Name
Irrigated Drill FDA UDI
Model / Reference
IM-P1742 FDA UDI
Description
Irrigated Drill FDA UDI

Identifiers

Catalog Number
P1742 FDA UDI
Primary DI / UDI-DI
D769IMP17420 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Fluted surgical drill bit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, single-use

Imtec by Park Dental Research Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluted surgical drill bit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Park Dental Research Corp

Sources (1)

  • FDA UDI 4d500c52-0f8c-4c3f-b19d-6643c55ad91c 35 fields · synced Jun 8, 2026