Identity
- Trade Name
- EZCROWNS EUDAMEDEZCrown FDA UDI
- Generic Name
- Preformed dental crown, temporary FDA UDI
- Device Name
- Sprig Posterior Crown -Mandibular Right First Molar (Space Loss) FDA UDISprig Anterior Crown -Maxillary Right Lateral FDA UDI
- Model / Reference
- R-EZC-A-D1 EUDAMEDFDA UDIEZCROWNS EUDAMEDR-EZC-P-S3SL FDA UDI
- Description
- Sprig Posterior Crown -Mandibular Right First Molar (Space Loss) FDA UDISprig Anterior Crown -Maxillary Right Lateral FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819235020017 EUDAMEDFDA UDI00819235020956 FDA UDI
- Basic UDI-DI
- 081923502EZCET EUDAMED
- 510(k) Number
- K091362 FDA UDI
- FDA Product Code
- ELZ FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Preformed dental crown, temporary FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3330 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Preformed dental crown, temporary
EZCrown by Sprig Oral Health Technologies, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Preformed dental crown, temporary.
- 3M™ Unitek™ — 3M COMPANY · Class I
- NuSmile BioFlx Anterior Central, Lateral and Cuspids - Professional Kit — NUSMILE, LTD · Class I
- NuSmile Pre-Contoured Stainless Steel Cuspid Crown - Mandibular, Size 2 — NUSMILE, LTD · Class I
- Acero Crowns XT Molar — PARK-ISTRE, LLC. · Class I
- NuSmile ZR Posterior Replacement Crown — NUSMILE, LTD · Class I
- NuSmile Pre-Contoured Stainless Steel Crown — NUSMILE, LTD · Class I
- NuSmile ZR Posterior Replacement Crown - First Primary Molar Maxillary Right, Si — NUSMILE, LTD · Class I
- Kids-e-crown — Kids-E-Dental Llp · Class I
Cleared under the same submission
K091362 also covers:
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, Inc.
- EZCrown — Sprig Oral Health Technologies, 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sprig Oral Health Technologies, Inc.
Sources (3)
- FDA UDI db346397-c7b0-4a42-b526-8846d1f5457d 34 fields · synced Jul 10, 2026
- FDA UDI 0c68e9a6-56c6-40f2-963d-de370197e1a2 34 fields · synced May 30, 2026
- EUDAMED ead566db-52b1-45c2-8930-c5527004d38f 61 fields · synced Jul 10, 2026