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Imtec

FDA UDI

Class II (US FDA UDI)

by Park Dental Research Corp

Identity

Trade Name
IMTEC FDA UDI
Generic Name
Organic solvent metabolite IVD, kit, liquid chromatography FDA UDI
Device Name
2.25 mm x 14 mm Collared Implant FDA UDI
Model / Reference
2214-CO FDA UDI
Description
2.25 mm x 14 mm Collared Implant FDA UDI

Identifiers

Primary DI / UDI-DI
D76922140 FDA UDI
510(k) Number
K121707 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Organic solvent metabolite IVD, kit, liquid chromatography FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Organic solvent metabolite IVD, kit, liquid chromatography

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

Similar devices

Also classified as Organic solvent metabolite IVD, kit, liquid chromatography.

Cleared under the same submission

K121707 also covers:

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 f1909f1a-9668-4187-ab5c-b6bb7557f2a0 35 fields · synced May 31, 2026