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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
Blade endosteal dental implant, two-piece FDA UDI
Device Name
Startanius Narrow Ridge Implant Standard FDA UDI
Model / Reference
IM-STAR11-8 FDA UDI
Description
Startanius Narrow Ridge Implant Standard FDA UDI

Identifiers

Catalog Number
STAR11-8 FDA UDI
Primary DI / UDI-DI
D769IMSTAR1180 FDA UDI
510(k) Number
K854749 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Blade endosteal dental implant, two-piece 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

Yes

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: Blade endosteal dental implant, two-piece

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

Similar devices

Also classified as Blade endosteal dental implant, two-piece.

Cleared under the same submission

K854749 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 341d18cf-4f52-4bb7-9e59-0272494d0a80 36 fields · synced Jun 8, 2026