← Back to catalogue
Crown HT A2
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SRI-0204065510(k) K242277
Identity
- Trade Name
- Crown HT A2 EUDAMEDCrown HT A2 Single-Unit Capsule FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Crown HT EUDAMEDSprintRay Crown HT 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-0204065 EUDAMEDFDA UDI
- Description
- SprintRay Crown HT 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
- 00850070544016 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850070544SRI-0204030D3 EUDAMED
- 510(k) Number
- K242277 FDA UDI
- FDA Product Code
- EBF FDA UDIEBG FDA UDIEBI FDA UDIELM FDA UDIPZY 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 UDI872.3770 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 — 4 Milliliter FDA UDI
Crown HT A2 by Sprintray, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242277 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0850070544SRI-0204030D3 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sprintray Inc.
- EUDAMED SRN
- US-MF-000036081
- FDA Applicant
- Sprintray, Inc.
- Authorised Representative
- SprintRay Europe GmbH DE-AR-000033436
Sources (3)
- EUDAMED 95c35c63-9627-4adb-b873-60e9ef3395b1 85 fields · synced Jun 18, 2026
- FDA UDI c13ac183-fee6-4ea6-bcb2-168803cb625a 36 fields · synced May 25, 2026
- FDA 510(k) K242277 1 fields · synced May 18, 2026