FDA UDI
Not in Commercial Distribution
🇺🇸 United States
N.A.
DI: J011164000000
·
Model: 164-000-00
·
DENTAURUM GmbH & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- N.A.
- Primary DI
- J011164000000
- Version / Model
- 164-000-00
- Company Name
- DENTAURUM GmbH & Co.KG
- Labeler DUNS
- 315427286
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 61576f18-aea1-4983-b53d-6a10152bee2d
- Distribution End Date
- 2022-09-16
Device Description
LinguSil transfer matrix for indirect bonding, Polyvinylsiloxane) / For further information please visit our online-shop on our website www.dentaurum.de
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 |
|---|---|---|---|---|
| EWL | PROSTHESIS, LARYNGEAL (TAUB) | Ear, Nose, Throat | 874.3730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18083 | Bite registration rim | A schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships. Bite rims can be individually made or adjusted to one patient from preformed devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J011164000000 | HIBCC |
Customer Contacts
- Phone
- +1(800)523-3946
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K913537 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage: 18 - 25 °C / 64.4 - 77 °F