Identity
- Trade Name
- Ceramic Crown - B1 - Single-unit Capsule 3-Pack FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer upon layer of the composite material. FDA UDI
- Model / Reference
- SRI-0204012 FDA UDI
- Description
- SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer upon layer of the composite material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704895 FDA UDI
- 510(k) Number
- K222623 FDA UDI
- FDA Product Code
- EBI FDA UDIEBF FDA UDIELM FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3690 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
- Total Volume — 12 Milliliter FDA UDI
Category: Dental appliance fabrication material, resin
Ceramic Crown - B1 - Single-unit Capsule 3-Pack 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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- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
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- FREEPRINT crown A1 500g — DETAX GmbH · Class II
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 - 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 - A2 — 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 e7a67c4d-a5dd-4e02-817a-b9b93a0ae948 37 fields · synced May 30, 2026