FDA UDI
In Commercial Distribution
🇺🇸 United States
Roydent
DI: D809PL2091
·
Model: PL209
·
ROYDENT DENTAL PRODUCTS INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Roydent
- Primary DI
- D809PL2091
- Version / Model
- PL209
- Catalog Number
- PL209
- Company Name
- ROYDENT DENTAL PRODUCTS INC
- Labeler DUNS
- 131487225
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 3
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 392706f7-cdc9-40ac-ae07-dd0e0aa2620e
Device Description
ENDO-CLEANSE 8oz. BOTTLE
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKL | POINT, SILVER, ENDODONTIC | Dental | 872.3840 | 1 |
| KIF | RESIN, ROOT CANAL FILLING | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45480 | Dental root surface conditioner | A dental material, typically of neutral pH, used for topical application on exposed/scaled root surfaces for the removal of the smear layer (adherent debris produced when cutting the enamel or dentin in cavity or endodontic preparation, Circa 1 micron thick) during dental/periodontal surgery. The material is removed (washed off) after the recommended period to expose the collagenous matrix of dentine surfaces. It is typically presented in the form of a gel and consists of, e.g., edetate disodium (EDTA) and carboxymethylcellulose (CMC) with a neutral pH. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D809PL2091 | HIBCC |
Customer Contacts
- Phone
- +1(800)992-7767
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 8 | Fluid Ounce |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a Cool Dry Place