FDA UDI
In Commercial Distribution
🇺🇸 United States
SDR® Plus Bulk Fill Flowable
DI: D00261C104P1
·
Model: 61C104P
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SDR® Plus Bulk Fill Flowable
- Primary DI
- D00261C104P1
- Version / Model
- 61C104P
- Catalog Number
- 61C104P
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-20
- Public Version
- 1
- Public Version Date
- 2022-09-28
- Public Version Status
- New
- Public Device Record Key
- d44077fb-a7be-49d9-926d-b85138ecafe3
Device Description
SDR® Plus Bulk Fill Flowable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| EBF | Material, tooth shade, resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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 | D00261C104P1 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 Syringe (1 g), 3 Syringe Tips |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from moisture.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight and store i a well ventilated place at temperatures between 2° and 24° C.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use after expiration date.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Inadequate storage conditions will shorten the shelf life and may lead to malfunction of the product.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Allow material to reach room temperature prior to use.