← Back to catalogue
Ortodontic Elastic - Latex - Medium 1/8"
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.01.310Model LATEX EXTRAORAL ELASTICSModel LATEX ELASTICS
Identity
- Trade Name
- Ortodontic Elastic - Latex - Medium 1/8" EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Ortodontic Elastic - Latex - Medium 1/8" FDA UDI
- Model / Reference
- LATEX EXTRAORAL ELASTICS EUDAMED60.01.310 EUDAMEDFDA UDILATEX ELASTICS EUDAMED
- Description
- Ortodontic Elastic - Latex - Medium 1/8" FDA UDI
Identifiers
- Catalog Number
- 60.01.310 FDA UDI
- Primary DI / UDI-DI
- 07895742133467 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742133467 EUDAMED7895742178GP 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
Yes
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
Ortodontic Elastic - Latex - Medium 1/8" by Dental Morelli Ltda. — Class I — MDR, MDD, 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
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- ELASTICO CORRENTE LONGO PINK CRISTAL RL 4, 5M — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- 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/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742133467 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742133467 | Class I | Active |
| 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
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED bbfe8094-e0b0-4060-b96a-07b0b6ef2c4b 61 fields · synced Jul 12, 2026
- EUDAMED a5f31f86-7da9-4ea3-b7e0-99d87d6a0fbf 61 fields · synced May 19, 2026
- FDA UDI 92a90a2c-0bee-484b-a9fc-26d76b2dad02 35 fields · synced May 30, 2026