FDA UDI
In Commercial Distribution
🇺🇸 United States
Patterson®
DI: D6620708507352
·
Model: 70850735
·
PATTERSON DENTAL SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
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Basic Information
- Brand Name
- Patterson®
- Primary DI
- D6620708507352
- Version / Model
- 70850735
- Catalog Number
- 70850735
- Company Name
- PATTERSON DENTAL SUPPLY, INC.
- Labeler DUNS
- 171843584
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2024-05-08
- Public Version
- 2
- Public Version Date
- 2024-09-02
- Public Version Status
- Update
- Public Device Record Key
- fdd0e27f-e387-45c5-8860-4e0bda5ad450
Device Description
ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATIONLOCATOR, ROOT APEX
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| EBZ | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | Dental | 872.6070 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D6620708507350 | HIBCC | ||||
| Primary | D6620708507352 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030568 | 000 |