Identity
- Trade Name
- Simplee® EUDAMEDFDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- DryZ Gingival Retraction Paste EUDAMEDSimplee® Retraction Paste (Lifco) (Pkg. of 30 Capsules) FDA UDI
- Model / Reference
- 156215 EUDAMEDFDA UDI
- Description
- Simplee® Retraction Paste (Lifco) (Pkg. of 30 Capsules) FDA UDI
Identifiers
- Catalog Number
- 156215 FDA UDI
- Primary DI / UDI-DI
- 10810000525710 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052DRYZXK EUDAMED
- Unit of Use DI
- 00810000525713 EUDAMED
- FDA Product Code
- MVL FDA UDI
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
- GMDN Term
- Gingival retraction cord, non-medicated FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gingival retraction cord, non-medicated
Simplee® by Parkell, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
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- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081000052DRYZXK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED b99f10df-09e5-40e5-ae23-1c2ff764a6a6 61 fields · synced Jun 19, 2026
- FDA UDI 1075d0a5-b261-4ad1-a436-ff83c86a6d13 36 fields · synced May 29, 2026