Precise Bite™
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Precise Bite™ FDA UDI
- Generic Name
- Radiological head/neck positioning mouthpiece FDA UDI
- Device Name
- Mouthpiece (small) with tongue depressor FDA UDI
- Model / Reference
- MTCBPBITETDS EUDAMEDFDA UDIHead, Neck, and Shoulder Devices EUDAMED
- Description
- Mouthpiece (small) with tongue depressor FDA UDI
Identifiers
- Catalog Number
- MTCBPBITETDS FDA UDI
- Primary DI / UDI-DI
- 00841439104095 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0005R05AY EUDAMED
- FDA Product Code
- IYE FDA UDILNH FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological head/neck positioning mouthpiece FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Radiological head/neck positioning mouthpiece
Precise Bite™ by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiological head/neck positioning mouthpiece.
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- PinPoint Vacuum Fixation Mouthpiece, Assorted, Box of 10 — Aktina Corp. · Class II
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- Precise Bite™ — Medtec LLC · Class II
- Precise Bite™ — Medtec LLC · Class II
Cleared under the same submission
K093738 also covers:
- AccuForm™ Cushion — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
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- Posicast® Thermoplastic — Medtec LLC
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- Posicast® Thermoplastic — Medtec LLC
- Posifix® Headrest — Medtec LLC
K933227 also covers:
- Fixator™ — Medtec LLC
- Fixator™ Shoulder Cups — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter with Backplate — Medtec LLC
- Prone Face Cushion — Medtec LLC
- Shim — Medtec LLC
- Shim — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI 6a7da81f-b847-4af5-9b58-d41a480c9f0f 36 fields · synced Sep 18, 2026
- EUDAMED 4caac1c1-18c1-4d07-849c-e79f3f7ef05a 61 fields · synced Sep 18, 2026