Identity
- Trade Name
- primostick FDA UDI
- Generic Name
- Removable dental occlusal splint, custom-made FDA UDI
- Model / Reference
- PS202US FDA UDI
Identifiers
- Primary DI / UDI-DI
- D831PS202US0 FDA UDI
- 510(k) Number
- K030832 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Removable dental occlusal splint, custom-made FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Removable dental occlusal splint, custom-made
primostick by Primotec Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Removable dental occlusal splint, custom-made.
- ProPlan CMF — Materialise NV · Class I
- Primeprint Splint SF 1000g — DETAX GmbH · Class I
- M-PM Crystal — Merz Dental GmbH · U
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Freeprint ortho 405 1000g — DETAX GmbH · Class I
- Vertex-Dental BV — Vertex-Dental B.V. · Class I
- M-PM Crystal — Merz Dental GmbH · U
- M-PM Crystal — Merz Dental GmbH · U
Cleared under the same submission
K030832 also covers:
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 U | Pending data |
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Manufacturer
- Manufacturer
- Primotec Llc
Sources (1)
- FDA UDI 7485c8a4-5c4a-44ac-99ea-a55b3eb1bf99 33 fields · synced Jun 8, 2026