FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
K Number: K102776
·
Decision Feb 18, 2011
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
6
Review Days
147
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Basic Information
- Device Name
- EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
- K Number
- K102776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deltamed GmbH
- Date Received
- September 24, 2010
- Decision Date
- February 18, 2011
- Product Code
- EBG
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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Other Clearances by Deltamed GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K243720 | 3Delta UNlimited | Dec 18, 2024 | Substantially Equivalent |
| K230341 | ACRIFIX | Apr 6, 2023 | Substantially Equivalent |
| K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix | Jan 10, 2022 | Substantially Equivalent |
| K211804 | 3Delta Crown | Dec 6, 2021 | Substantially Equivalent |
| K200039 | P pro Crown & Bridge | Jul 31, 2020 | Substantially Equivalent |