Identity
- Trade Name
- Cinch® EUDAMEDCinch™ FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Cinch, Mousse & Mach Impression Materials EUDAMED380ml. Super-Size Cartridge Cinch™ 90 Medium-Body (For Pentamix Dispensers) FDA UDI
- Model / Reference
- S464 EUDAMEDFDA UDI
- Description
- 380ml. Super-Size Cartridge Cinch™ 90 Medium-Body (For Pentamix Dispensers) FDA UDI
Identifiers
- Catalog Number
- S464 FDA UDI
- Primary DI / UDI-DI
- 00810000524075 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052IMPRESSIONL3 EUDAMED
- Direct Marketing DI
- 00810000524075 EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 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: Silicone dental impression material
Cinch® by Parkell, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
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- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · 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 | 081000052IMPRESSIONL3 | 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 4f41b6e8-835c-408d-9607-63ea5806657d 61 fields · synced Jun 17, 2026
- FDA UDI 02a640f1-678b-49a6-92a8-d6aed45127a4 36 fields · synced May 30, 2026