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Ceramic Crown C2 Single-unit Capsule 3-Pack
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref SRI-0204015
Identity
- Trade Name
- Ceramic Crown - C2 - Single-Unit Capsule 3-Pack EUDAMEDCeramic Crown C2 Single-unit Capsule 3-Pack FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Ceramic Crown EUDAMEDSprintRay Ceramic 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-0204015 EUDAMEDFDA UDI
- Description
- SprintRay Ceramic 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
- 00850070544207 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039704SRI-0202057HE EUDAMED
- 510(k) Number
- K222623 FDA UDI
- FDA Product Code
- EBF FDA UDIEBI FDA UDIELM FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3760 FDA UDI872.3590 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 C2 Single-unit Capsule 3-Pack 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
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 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 (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 9ff747ac-8000-40aa-965a-a40f1ea0ca30 36 fields · synced Jul 8, 2026
- EUDAMED 1b95b94d-dd68-42f9-9f6e-691f6949ade2 61 fields · synced Jul 8, 2026