S.I.N. Implant System Ltda
Sao Paulo, BR
S.I.N. Implant System Ltda appears in FDA device records in Sao Paulo, BR. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to S.I.N. Implant System Ltda carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- S.I.N. – Sistema DE Implante Nacional S.A.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 21 510(k) clearances for S.I.N. Implant System Ltda between 2017 and 2025. The busiest year on record is 2022, with 4. The most recent is 2025, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2020 | 3 |
| 2021 | 3 |
| 2022 | 4 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | DZE | Substantially Equivalent | |
| K252266 | S.I.N. Dental Implant System | NHA | Substantially Equivalent | |
| K251262 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K251046 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K240609 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K241378 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | |
| K232821 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K231127 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K230069 | S.I.N. Dental Implant System | NHA | Substantially Equivalent | |
| K221453 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K222514 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | |
| K222231 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K222005 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | |
| K212404 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | |
| K211921 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K203725 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K200992 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K201688 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | |
| K193096 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | |
| K170392 | S.I.N. Implant System | DZE | Substantially Equivalent | |
| K170398 | S.I.N. Dental Implant System | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004201263 | 3004201263 | S.I.N. Implant System Ltda | Rua Soldador Ocimar Guimaraes da Silva 421, SAO PAULO 03348-060 BR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0017-2026 | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N | Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance. | Class II | Open, Classified | |
| Z-0920-2025 | Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N | Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain