FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRINK PRE-MAXILLARY IMPLANT
K Number: K921580
·
Decision May 6, 1992
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
41
Applicant Total
41
Review Days
34
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Basic Information
- Device Name
- BRINK PRE-MAXILLARY IMPLANT
- K Number
- K921580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Implantech Associates, Inc.
- Date Received
- April 2, 1992
- Decision Date
- May 6, 1992
- Product Code
- FZE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Implantech Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200610 | Customized Contour Implant | Dec 23, 2020 | Substantially Equivalent |
| K191130 | Customized Contour Implant | Aug 23, 2019 | Substantially Equivalent |
| K172389 | ePTFE-Coated Auricular Implant | Jul 18, 2018 | Substantially Equivalent |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | Jul 10, 2014 | Substantially Equivalent |
| K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX | Aug 31, 2007 | Substantially Equivalent |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | Nov 4, 2005 | Substantially Equivalent |
| K052505 | CALF IMPLANT, MODEL EC17-X | Nov 4, 2005 | Substantially Equivalent |
| K013732 | GELZONE | Feb 7, 2002 | Substantially Equivalent |
| K012419 | CONFORM SHEETING, MODEL IGEL | Oct 24, 2001 | Substantially Equivalent |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Nov 24, 2000 | Substantially Equivalent |