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Rotator Elastic Crystal
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.07.100Model ROTATOR ELASTIC
Identity
- Trade Name
- Rotator Elastic Crystal EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Rotator Elastic Crystal FDA UDI
- Model / Reference
- ROTATOR ELASTIC EUDAMED60.07.100 EUDAMEDFDA UDI
- Description
- Rotator Elastic Crystal FDA UDI
Identifiers
- Catalog Number
- 60.07.100 FDA UDI
- Primary DI / UDI-DI
- 07895742008871 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742180GA EUDAMEDB-07895742008871 EUDAMED
- FDA Product Code
- ECI FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic archwire/bracket ligature FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Portugal 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic retainer
Rotator Elastic Crystal by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic retainer.
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
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- MASTER POUCH 15 2G 3/16 LT COUGAR — Ormco Corporation · Class IIa
- Pre-Finisher — TP ORTHODONTICS, INC. · Class I
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742180GA | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742180GA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED e2e9f0bc-259a-4f6d-9592-980a46e6ec50 61 fields · synced Jul 30, 2026
- EUDAMED 8984d6b9-a2a5-4ece-b5b4-e386d62f09c1 61 fields · synced May 19, 2026
- FDA UDI 601fc114-2e4e-4640-984d-927b41c796a6 35 fields · synced May 30, 2026