Identity
- Trade Name
- DryZ® EUDAMEDDryz™ FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- DryZ Gingival Retraction Paste EUDAMEDDryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) FDA UDI
- Model / Reference
- S180 EUDAMEDFDA UDI
- Description
- Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) FDA UDI
Identifiers
- Catalog Number
- S180 FDA UDI
- Primary DI / UDI-DI
- 10810000525086 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052DRYZXK EUDAMED
- Unit of Use DI
- 00810000525089 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
- 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
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
DryZ® by Parkell, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Gingival retraction cord, non-medicated.
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- 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 36a91989-01da-4a83-ae8d-75eec0843493 61 fields · synced Jun 19, 2026
- FDA UDI 43fe5f0e-e016-4ce4-b805-a26c005cb81d 36 fields · synced May 25, 2026