Identity
- Trade Name
- APEX Base - Light Pink - 3kg FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material. FDA UDI
- Model / Reference
- SRI-0202191 FDA UDI
- Description
- SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850070544412 FDA UDI
- 510(k) Number
- K221678 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 3 Kilogram FDA UDI
Category: Dental appliance fabrication material, resin
APEX Base - Light Pink - 3kg by Sprintray, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, resin.
- O-Cryl Self Curing Acrylic Shade White X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- PREMIUM — Lang Dental Manufacturing Company, Inc. · Class II
- Axcent Acrylics — GARRECO, LLC · Class II
- smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
- vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
- HI-I® — FRICKE INTERNATIONAL, INC. · Class II
- FREEPRINT crown A1 500g — DETAX GmbH · Class II
Cleared under the same submission
K221678 also covers:
- APEX Base - Dark Reddish Pink - 3kg — Sprintray, Inc.
- APEX Base - Opaque Original Pink - 3kg — Sprintray, Inc.
- APEX Base - Original Pink - 3kg — Sprintray, Inc.
- SprintRay High Impact Denture Base - Bubblegum — Sprintray, Inc.
- SprintRay High Impact Denture Base - Dark Meharry — Sprintray, Inc.
- SprintRay High Impact Denture Base - Dark Pink — Sprintray, Inc.
- SprintRay High Impact Denture Base - Light Meharry — Sprintray, Inc.
- SprintRay High Impact Denture Base - Light Pink — Sprintray, Inc.
- SprintRay High Impact Denture Base - Original Meharry — Sprintray, Inc.
- SprintRay High Impact Denture Base - Original Pink — Sprintray, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
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Manufacturer
- Manufacturer
- Sprintray, Inc.
Sources (2)
- FDA UDI 47be4010-fc1b-44a5-a906-d8d45e2de698 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026