FDA UDI
In Commercial Distribution
🇺🇸 United States
VOCO Retraction Paste
DI: E22110131
·
Model: 1013
·
VOCO GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- VOCO Retraction Paste
- Primary DI
- E22110131
- Version / Model
- 1013
- Catalog Number
- 1013
- Company Name
- VOCO GmbH
- Labeler DUNS
- 316699578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-12-14
- Public Version
- 1
- Public Version Date
- 2021-12-22
- Public Version Status
- New
- Public Device Record Key
- 7697f94c-e9ed-4c8b-b59f-78bd7bbbe41d
Device Description
Material for the temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g. analogue or digital impressions, cementation of temporary and permanent restorations or preparation of class II and V fillings.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| MVL | Cord, Retraction | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46423 | Gingival retraction solution | A liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. 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 | E22110130 | HIBCC | ||||
| Primary | E22110131 | HIBCC |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213149 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 23 Degrees Celsius