FDA UDI
In Commercial Distribution
🇺🇸 United States
ProRoot MTA
DI: D716PRCEM1
·
Model: PRCEM
·
TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- ProRoot MTA
- Primary DI
- D716PRCEM1
- Version / Model
- PRCEM
- Catalog Number
- PRCEM
- Company Name
- TULSA DENTAL PRODUCTS LLC
- Labeler DUNS
- 942778564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 3
- Public Version Date
- 2024-11-04
- Public Version Status
- Update
- Public Device Record Key
- ba54f0b5-e46e-4f15-8044-65174fa6c5f7
Device Description
ProRoot: Gray MTA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KIF | RESIN, ROOT CANAL FILLING | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34771 | Dental unfilled resin sealant/coating | A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. 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 | D716PRCEM1 | HIBCC | ||||
| Unit of Use | D716PRCEM0 | HIBCC |
Customer Contacts
- Phone
- +1(800)662-1202
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a Cool Dry Place