Identity
- Trade Name
- StarDental Instrument Solutions FDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Device Name
- HIFLO 4-LINE FO SWIVEL FDA UDI
- Model / Reference
- 263758 FDA UDI
- Description
- HIFLO 4-LINE FO SWIVEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7022637580 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
- 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Pneumatic dental handpiece coupler
StarDental Instrument Solutions by Dentalez, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic dental handpiece coupler.
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- RA-24 Roto Quick 6-Hole — W & H Dentalwerk Bürmoos GmbH · Class I
- Airlight — Beyes Dental Canada Inc · Class I
- MK-dent Germany® — MK-Dent GmbH · Class I
- Airlight — Beyes Dental Canada Inc · Class I
- DENTALAIRE — Beyes Dental Canada Inc · Class I
Cleared under the same submission
K153411 also covers:
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutions — DENTALEZ, INC.
- StarDental Instrument Solutionss — DENTALEZ, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentalez, Inc.
Sources (1)
- FDA UDI 0b2dc4a7-b411-481c-9521-97ae6a1cb9ba 35 fields · synced Jun 8, 2026