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StarDental Instrument Solutions

FDA UDI

Class I (US FDA UDI)

by Dentalez, Inc.

Identity

Trade Name
StarDental Instrument Solutions FDA UDI
Generic Name
Pneumatic dental handpiece coupler FDA UDI
Device Name
HIFLO 6-PIN SWIVEL, 3.3V SATIN, LED FDA UDI
Model / Reference
268844 FDA UDI
Description
HIFLO 6-PIN SWIVEL, 3.3V SATIN, LED FDA UDI

Identifiers

Primary DI / UDI-DI
D7022688440 FDA UDI
510(k) Number
K153411 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Pneumatic dental handpiece coupler FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

StarDental Instrument Solutions by Dentalez, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153411 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentalez, Inc.

Sources (1)

  • FDA UDI 7061ed7b-562b-4a13-af7f-97f57e91b1ae 36 fields · synced May 30, 2026