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Pink Petal™ - Saliva Ejector Holder - 100 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50Z976
Identity
- Trade Name
- Pink Petal™ - Saliva Ejector Holder - 100 Count EUDAMEDFDA UDI
- Generic Name
- Intraoral dental suction tip holder FDA UDI
- Device Name
- Pink Petal™ EUDAMEDPink Petal™ - Saliva Ejector Holder - 100 Count Pink Petal™ is a device comprised of a single piece that is made out of TPE-S Pink Petal™ is an attachment to the saliva suction tip for dental treatments. It will get placed on the suction tip end to keep it in place and provide a hands-free treatment area. FDA UDI
- Model / Reference
- 50Z976 EUDAMEDFDA UDI
- Description
- Pink Petal™ - Saliva Ejector Holder - 100 Count Pink Petal™ is a device comprised of a single piece that is made out of TPE-S Pink Petal™ is an attachment to the saliva suction tip for dental treatments. It will get placed on the suction tip end to keep it in place and provide a hands-free treatment area. FDA UDI
Identifiers
- Catalog Number
- 50Z976 FDA UDI
- Primary DI / UDI-DI
- 00840161310668 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300073D EUDAMED
- FDA Product Code
- DYN FDA UDI
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
- GMDN Term
- Intraoral dental suction tip holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 15.9 Centimeter FDA UDIWidth — 12.7 Centimeter FDA UDI
Pink Petal™ - Saliva Ejector Holder - 100 Count by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0840161300073D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (2)
- EUDAMED 0aecf0a8-72e8-4d37-a0dc-052ed8e898e5 61 fields · synced Jun 17, 2026
- FDA UDI 4cc7f831-725c-4460-9dab-0b389b2438c5 35 fields · synced May 30, 2026