Intra-Lock International: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Intra-Lock International” (first 2002, latest 2017), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 174 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 191 |
| 2014 | 1 | 115 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 128 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intra-Lock International took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 8 | 8 |
| NHA | Abutment, Implant, Dental, Endosseous | 3 | 3 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Review panels
- Dental (12)
- Orthopedic (1)
Most recent Intra-Lock International 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171831 | Intra-Lock Bone Fixation System | DZL | 2017-10-26 | 128 |
| K133613 | INTRA-LOCK DENTAL IMPLANTS | DZE | 2014-03-20 | 115 |
| K130140 | INTRA-LOCK OP DENTAL IMPLANT | DZE | 2013-08-01 | 191 |
| K111199 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS | NHA | 2011-08-08 | 102 |
| K103194 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM | DZE | 2011-04-21 | 174 |
| K082419 | REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 | MQV | 2009-05-27 | 278 |
| K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS | NHA | 2008-05-21 | 79 |
| K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM | DZE | 2007-10-12 | 224 |
| K050970 | MILO DENTAL IMPLANT SYSTEM | DZE | 2005-10-14 | 179 |
| K040205 | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS | NHA | 2004-03-22 | 52 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intra-Lock International.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Intra-Lock International?
FDA lists 13 510(k) clearances under the applicant name “Intra-Lock International” (first 2002, latest 2017), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intra-Lock International?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intra-Lock International is 174 days.
Which FDA product codes appear under Intra-Lock International?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 8); NHA (Abutment, Implant, Dental, Endosseous, 3); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 13 Intra-Lock International clearances with predicates and recalls
- Run predicate analysis for product code DZE, Intra-Lock International's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.