FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGENIC® GuttaFlow®2
DI: E165600137100
·
Model: INTROKIT
·
Coltène/Whaledent GmbH + Co. KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYGENIC® GuttaFlow®2
- Primary DI
- E165600137100
- Version / Model
- INTROKIT
- Catalog Number
- 60013710
- Company Name
- Coltène/Whaledent GmbH + Co. KG
- Labeler DUNS
- 315494443
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fda710e6-1880-4d1b-9e83-24e9b48dc5bd
Device Description
The HYGENIC® GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + Stops (20 pcs), 1 x Adapters for RotoMix™( 3 pcs), 1 x Dispenser, 1 x HYGENIC® Gutta Percha Points ISO 15-40 sample (100 pcs) and 1 x HYGENIC® Spectra Point® Gutta Percha Points Greater Taper 0.04 20-45 sample (60 pcs).
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
- 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 |
|---|---|---|---|---|
| EKM | Gutta-Percha | Dental | 872.3850 | 1 |
| KIF | Resin, Root Canal Filling | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36095 | Endodontic filling/sealing material | A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include (but are not limited to) silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). It does not include gutta-percha. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E165600137100 | HIBCC |
Customer Contacts
- Phone
- +4973458050
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032662 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 24 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 64 – 75 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from sunlight