Identity
- Trade Name
- Crown - A2 FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. FDA UDI
- Model / Reference
- SRI-0202178 FDA UDI
- Description
- SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704819 FDA UDI
- 510(k) Number
- K222623 FDA UDI
- FDA Product Code
- EBF FDA UDIEBI FDA UDIELM FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3760 FDA UDI872.3590 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 — 250 Gram FDA UDI
Category: Dental appliance fabrication material, resin
Crown - A2 by Sprintray, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, resin.
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- smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
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Cleared under the same submission
K222623 also covers:
- Ceramic Crown - A1 - Single-unit Capsule 3-Pack — Sprintray, Inc.
- Ceramic Crown - A2 - Single-unit Capsule 3-Pack — Sprintray, Inc.
- Ceramic Crown - B1 - Single-unit Capsule 3-Pack — Sprintray, Inc.
- Ceramic Crown - Bleach - Single-unit Capsule 3-Pack — Sprintray, Inc.
- Ceramic Crown A3 Single-unit Capsule 3-Pack — Sprintray, Inc.
- Ceramic Crown C2 Single-unit Capsule 3-Pack — Sprintray, Inc.
- Ceramic Crown D2 Single-unit Capsule 3-Pack — Sprintray, Inc.
- Ceramic Crown D3 Single-unit Capsule 3-Pack — Sprintray, Inc.
- Crown - A1 — Sprintray, Inc.
- Crown - A3 — Sprintray, Inc.
- Crown - B1 — Sprintray, Inc.
- Crown - B3 — Sprintray, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Sprintray, Inc.
Sources (1)
- FDA UDI cf2e49bf-f0ca-4ccc-933b-439d83236ea9 37 fields · synced Jun 8, 2026