FDA UDI
In Commercial Distribution
🇺🇸 United States
Pink Petal™ - Saliva Ejector Holder - 3 Count Sample Pack
DI: 00840161311788
·
Model: 50Z976SMPL-US
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Pink Petal™ - Saliva Ejector Holder - 3 Count Sample Pack
- Primary DI
- 00840161311788
- Version / Model
- 50Z976SMPL-US
- Catalog Number
- 50Z976
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-19
- Public Version
- 1
- Public Version Date
- 2026-02-27
- Public Version Status
- New
- Public Device Record Key
- c1be8b7c-3259-403b-b113-42da35679b94
Device Description
Pink Petal™ - Saliva Ejector Holder - 3 Count Sample Pack 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYN | Mouthpiece, Saliva Ejector | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63670 | Intraoral dental suction tip holder | A non-sterile semi-flexible device intended to be attached to the distal end of a dental suction tip and held between the teeth and cheek of a patient, to allow for hands-free suction during a dental procedure. It is typically a flat disk made of synthetic polymer materials with a clip/loop for attachment to the suction tip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840161311788 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15.9 | Centimeter | |
| Width | 12.7 | Centimeter |