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PinPoint Vacuum Fixation Mouthpiece, Medium, Box of 10
FDA UDIClass II (US FDA UDI)
by Aktina Corp.
Identity
- Trade Name
- PinPoint Vacuum Fixation Mouthpiece, Medium, Box of 10 FDA UDI
- Generic Name
- Radiological head/neck positioning mouthpiece FDA UDI
- Model / Reference
- 50-460 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365504601 FDA UDI
- 510(k) Number
- K103616 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological head/neck positioning mouthpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
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
Yes
FDA UDI
Category: Radiological head/neck positioning mouthpiece
PinPoint Vacuum Fixation Mouthpiece, Medium, Box of 10 by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological head/neck positioning mouthpiece.
- Panoramic — Young Innovations, Inc. · Class I
- Precise Bite™ — Medtec LLC · Class II
- Precise Bite™ — Medtec LLC · Class II
- TruGuard™ — Bionix, LLC · Class II
- Precise Bite™ — Medtec LLC · Class II
- Precise Bite™ — Medtec LLC · Class II
- PinPoint Vacuum Fixation Mouthpiece, Small, Box of 10 — Aktina Corp. · Class II
- PinPoint Vacuum Fixation Mouthpiece, Assorted, Box of 10 — Aktina Corp. · Class II
Cleared under the same submission
K103616 also covers:
- Adjustable Knee Support — Aktina Corp.
- Arch Kit, PositionPro — Aktina Corp.
- ArmAssist, PositionPro — Aktina Corp.
- Carbon Fiber Base Board, Head and Neck — Aktina Corp.
- Carbon Fiber Base Board, Long — Aktina Corp.
- Carbon Fiber Board, Short — Aktina Corp.
- Carbon Fiber Head Cradle Assembly — Aktina Corp.
- Cranial Localizer, Non-Stereotactic — Aktina Corp.
- Cranial Stereotactic Localizer Frame — Aktina Corp.
- Crossbar Assembly — Aktina Corp.
- Crossbar Assembly — Aktina Corp.
- Foot Stabilizer — Aktina Corp.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Aktina Corp.
Sources (1)
- FDA UDI 95350f1f-e6fd-472e-bfed-3c81f5257147 33 fields · synced May 30, 2026