FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GuttaSil Refill
DI: 08806387894117
·
Model: 9411
·
Meta Biomed Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GuttaSil Refill
- Primary DI
- 08806387894117
- Version / Model
- 9411
- Company Name
- Meta Biomed Co., Ltd.
- Labeler DUNS
- 688322841
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-24
- Public Version
- 2
- Public Version Date
- 2022-01-20
- Public Version Status
- Update
- Public Device Record Key
- 9d6f0d62-cebb-448a-8d46-f914419b31f8
- Distribution End Date
- 2021-02-02
Device Description
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.
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
- Yes
- 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 |
|---|---|---|---|---|
| 60510 | Hygroscopic dental cement | A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806387894117 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190510 | 000 |