Manufacturer registered with FDA
CAMLOG Biotechnologies GmbH
Basel, Switzerland. Lists 5 dental device types with FDA across 2 registered establishments, and holds 14 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 307
- 510(k) clearances
- 142006–2020
- Markets registered in
- 13892 registrations outside the US
- Establishments
- 2Switzerland, Germany
510(k) clearances per year, 2000–2026
Registered in 13 markets
Where regulators' registries name CAMLOG Biotechnologies GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: SwitzerlandOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | CAMLOG Biotechnologies GmbH | 14 clearances | 2006–2020 | Below |
| Saudi Arabia | SFDA | Manufacturer | ALTATEC GmbH | 360 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ALTATEC GMBH | 225 | 2009–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ALTATEC GmbH | 164 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ALTATEC GMBHAltatec GmbH | 39 | 2006–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | ALTATEC GmbH | 35 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Altatec GmbH | 34 | 2016–2022 | Pure Global AI |
| China | NMPA | Registration holder | 安钛科齿科有限责任公司ALTATEC GmbH安钛科齿科有限责任公司 ALTATEC GmbH | 12 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ALTATEC GMBH | 9 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ALTATEC GmbHAltatec GmbH · Altatec GmbH. | 7 | 2001–2011 | Pure Global AI |
| Egypt | EDA | Manufacturer | Altatec GmbH,ALTATEC GmbH, | 5 | 2026–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Altatec GmbH | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ALTATEC GmbH | 1 | 2019–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What CAMLOG Biotechnologies GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2008 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2009 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | A2050.2600 Drill for CT-tube (for A2002.2000), d 2.6 mmA2050.2600 Template drill for placement of CT-tubesA2050.2600 Template drill for placement of CT-tubes d 2.6 mmA2050.2800 Drill for CT-tube (for A2222.2200), d 2.8 mmA2050.2800 Template drill for placement of CT-tubesA2050.2800 Template drill for placement of CT-tubes d 2.8 mmH5300070 Surgery set CERALOG® PROGRESSIVE-LINE FlexJ3713.3300 Guide Template drillJ3713.3300 Guide Template drill d 3.3 mmJ3713.4300 Guide Template drill 267 moreJ3713.4300 Guide Template drill d 3.8/4.3 mmJ3713.5555 Template drill Camlog GuideJ3733.3300 Guide Template drillJ3733.3300 Guide Template drill d 3.3 mmJ3733.4300 Guide Template drillJ3733.4300 Guide Template drill d 3.8/4.3 mmJ3753.3300 Guide Template drill, PL, d 3.3 mmJ3753.4300 Guide Template drill, PL, d 3.8/4.3 mmJ3753.5000 Guide Template drill d 5 mmJ5002005 Drill extensionJ5002005 Drill extension, ISO shaftJ5003.3350 Bone profiler d= 5 for d= 3.3 mm, stainless steelJ5003.4360 Bone profiler d= 6 for d= 3.8 and 4.3 mm, stainless steelJ5003.5070 Bone profiler d= 7 for d= 5 mm, stainless steelJ5004.3300 Baring drill for cover screw, for d 3.3 mmJ5004.3800 Baring drill for cover screw, for d 3.8 mmJ5004.4300 Baring drill for cover screw, for d 4.3 mmJ5004.5000 Baring drill for cover screw, for d 5 mmJ5006.3346 Countersink d 4.6, for d 3.3 mmJ5006.3852 Countersink d 5.2, for d 3.8 mmJ5006.4356 Countersink d 5.6, for d 4.3 mmJ5006.5063 Countersink d 6.3, for d 5 mmJ5015.3300 Depth stop for form drills SCREW-LINE d 3.3 mmJ5015.3300 Depth stop for form drills SCREW-LINE, with reduced coil d 3.3 mmJ5015.3800 Depth stop for form drills SCREW-LINE d 3.8 mmJ5015.3800 Depth stop for form drills SCREW-LINE, with reduced coil d 3.8 mmJ5015.4300 Depth stop for form drills SCREW-LINE d 4.3 mmJ5015.4300 Depth stop for form drills SCREW-LINE, with reduced coil d 4.3 mmJ5015.5000 Depth stop for form drills SCREW-LINE d 5 mmJ5015.5000 Depth stop for form drills SCREW-LINE, with reduced coil d 5 mmJ5015.6000 Depth stop for form drills SCREW-LINE d 6 mmJ5015.6000 Depth stop for form drills SCREW-LINE, with reduced coil d 6 mmJ5015007 Depth stop SCREW-LINE for pilot drill (J5051.2000) and pre-drill (J5051.2800) L 7 mmJ5015007 Depth stop, SCREW-LINE, f. pilot drill and pre-drill L 7 mmJ5015009 Depth stop SCREW-LINE for pilot drill (J5051.2000) and pre-drill (J5051.2800) L 9 mmJ5015009 Depth stop SCREW-LINE, f. pilot drills and pre-drills L 9 mmJ5015011 Depth stop SCREW-LINE for pilot drill (J5051.2000) and pre-drill (J5051.2800) L 11 mmJ5015011 Depth stop SCREW-LINE, f. pilot drills and pre-drills L 11 mmJ5015013 Depth stop SCREW-LINE for pilot drill (J5051.2000) and pre-drill (J5051.2800) L 13 mmJ5015013 Depth stop SCREW-LINE, f. pilot drills and pre-drills L 13 mmJ5036820 Spiral drill reverse action for CAMLOG® and CONELOG® Re-Set, d 0.82 mm,J5036820 Spiral drill, reverse action d 0.82 mm,J5041.3303 Guide Gingiva punch d 3.3 mmJ5041.3304 Guide Gingiva punch, PL, d 3.3 mmJ5041.3803 Guide Gingiva punch d 3.8 mmJ5041.3804 Guide Gingiva punch, PL, d 3.8 mmJ5041.4303 Guide Gingiva punch d 4.3 mmJ5041.4304 Guide Gingiva punch, PL, d 4.3 mmJ5041.5004 Guide Gingiva punch, PL, d 5 mmJ5050.2300 Round bur, d 2.3 mmJ5050.3500 Round bur, d 3.5 mmJ5051.1500 Point drill, d 1.5 mmJ5051.2000 Pilot drill SCREW-LINE, reduced coil d 2 mmJ5051.2000 Pilot drill, reduced coil d 2 mmJ5051.2003 Pilot drill without coil d 2 mmJ5051.2800 Pre-drill SCREW-LINE d 1.7-2.8 mmJ5053.3316 Form drill SCREW-LINE, Cortical bone d 3.3 mmJ5053.3816 Form drill SCREW-LINE, Cortical bone d 3.8 mmJ5053.4316 Form drill SCREW-LINE, Cortical bone d 4.3 mmJ5053.5016 Form drill SCREW-LINE, Cortical bone d 5 mmJ5053.6016 Form drill SCREW-LINE, Cortical bone d 6 mmJ5054.3309 Tap SCREW-LINE d 3.3 mmJ5054.3309 Tap SCREW-LINE, with hexagon, d 3.3 mmJ5054.3809 Tap SCREW-LINE d 3.8 mmJ5054.3809 Tap SCREW-LINE, with hexagon, d 3.8 mmJ5054.4309 Tap SCREW-LINE d 4.3 mmJ5054.4309 Tap SCREW-LINE, with hexagon, d 4.3 mmJ5054.5009 Tap SCREW-LIN d 5 mmJ5054.5009 Tap SCREW-LINE, with hexagon, d 5 mmJ5054.6009 Tap SCREW-LINE d 6 mmJ5054.6009 Tap SCREW-LINE, with hexagon, d 6 mmJ5062.3309 Form drill SCREW-LINE d 3.3 mm, L 9 mmJ5062.3311 Form drill SCREW-LINE d 3.3 mm, L 11 mmJ5062.3313 Form drill SCREW-LINE d 3.3 mm, L 13 mmJ5062.3316 Form drill SCREW-LINE d 3.3 mm, L 16 mmJ5062.3807 Form drill SCREW-LINE d 3.8 mm, L 7 mmJ5062.3809 Form drill SCREW-LINE d 3.8 mm, L 9 mmJ5062.3811 Form drill SCREW-LINE d 3.8 mm, L 11 mmJ5062.3813 Form drill SCREW-LINE d 3.8 mm, L 13 mmJ5062.3816 Form drill SCREW-LINE d 3.8 mm, L 16 mmJ5062.4307 Form drill SCREW-LINE d 4.3 mm, L 7 mmJ5062.4309 Form drill SCREW-LINE d 4.3 mm, L 9 mmJ5062.4311 Form drill SCREW-LINE d 4.3 mm, L 11 mmJ5062.4313 Form drill SCREW-LINE d 4.3 mm, L 13 mmJ5062.4316 Form drill SCREW-LINE d 4.3 mm, L 16 mmJ5062.5007 Form drill SCREW-LINE d 5 mm, L 7 mmJ5062.5009 Form drill SCREW-LINE d 5 mm, L 9 mmJ5062.5011 Form drill SCREW-LINE d 5 mm, L 11 mmJ5062.5013 Form drill SCREW-LINE d 5 mm, L 13 mmJ5062.5016 Form drill SCREW-LINE d 5 mm, L 16 mmJ5062.6009 Form drill SCREW-LINE d 6 mm, L 9 mmJ5062.6011 Form drill SCREW-LINE d 6 mm, L 11 mmJ5062.6013 Form drill SCREW-LINE d 6 mm, L 13 mmJ5062.6016 Form drill SCREW-LINE d 6 mm, L 16 mmJ5063.3309 Guide Pilot drill set, d 2 mm, internal irrigation d 3.3 mm L 9 mm d 3.3 L 9J5063.3311 Guide Pilot drill set, d 2 mm, internal irrigation d 3.3 mm L 11 mm d 3.3 L 9J5063.3313 Guide Pilot drill set, d 2 mm, internal irrigation d 3.3 mm L 13 mm d 3.3 L 13J5063.4307 Guide Pilot drill set, d 2 mm, internal irrigation d 3.8/4.3 mm L 7 mm d 3.8/4.3 L 7J5063.4309 Guide Pilot drill set, d 2 mm, internal irrigation d 3.8/4.3 mm L 9 mm d 3.8/4.3 L 9J5063.4311 Guide Pilot drill set, d 2 mm, internal irrigation d 3.8/4.3 mm L 11 mm d 3.8/4.3 L 11J5063.4313 Guide Pilot drill set, d 2 mm, internal irrigation d 3.8/4.3 mm L 13 mm d 3.8/4.3 L 13J5064.3316 Guide Pilot drill, d 2 mm, internal irrigation d 3.3 mm L 16 mm d 3.3 L 16J5064.4316 Guide Pilot drill, d 2 mm, internal irrigation d 3.8/4.3 mm L 16 mm d 3.8/4.3 L 16J5065.3309 Guide Surgery set, SL, internal irrigation d 3.3 mm L 9 mm d 3.3 L 9J5065.3311 Guide Surgery set, SL, internal irrigation d 3.3 mm L 11 mm d 3.3 L 11J5065.3313 Guide Surgery set, SL, internal irrigation d 3.3 mm L 13 mm d 3.3 L 13J5065.3807 Guide Surgery set, SL, internal irrigation d 3.8 mm L 7 mm d 3.8 L 7J5065.3809 Guide Surgery set, SL, internal irrigation d 3.8 mm L 9 mm d 3.8 L 9J5065.3811 Guide Surgery set, SL, internal irrigation d 3.8 mm L 11 mm d 3.8 L 11J5065.3813 Guide Surgery set, SL, internal irrigation d 3.8 mm L 13 mm d 3.8 L 13J5065.4307 Guide Surgery set, SL, internal irrigation d 4.3 mm L 7 mm d 4.3 L 7J5065.4309 Guide Surgery set, SL, internal irrigation d 4.3 mm L 9 mm d 4.3 L 9J5065.4311 Guide Surgery set, SL, internal irrigation d 4.3 mm L 11 mm d 4.3 L 11J5065.4313 Guide Surgery set, SL, internal irrigation d 4.3 mm L 13 mm d 4.3 L 13J5066.3316 Guide Form drill, SL, internal irrigation d 3.3 mm L 16 mm d 3.3 L 16J5066.3816 Guide Form drill, SL, internal irrigation d 3.8 mm L 16 mm d 3.8 L 16J5066.4316 Guide Form drill, SL, internal irrigation d 4.3 mm L 16 mm d 4.3 L 16J5068.3309 Guide Form drill, SL, cortical bone d 3.3 mm L 9 mm d 3.3 L 9J5068.3311 Guide Form drill, SL, cortical bone d 3.3 mm L 11 mm d 3.3 L 11J5068.3313 Guide Form drill, SL, cortical bone d 3.3 mm L 13 mm d 3.3 L 13J5068.3316 Guide Form drill, SL, cortical bone d 3.3 mm L 16 mm d 3.3 L 16J5068.3807 Guide Form drill, SL, cortical bone d 3.8 mm L 7 mm d 3.3 L 7J5068.3809 Guide Form drill, SL, cortical bone d 3.8 mm L 9 mm d 3.3 L 9J5068.3811 Guide Form drill, SL, cortical bone d 3.8 mm L 11 mm d 3.3 L 11J5068.3813 Guide Form drill, SL, cortical bone d 3.8 mm L 13 mm d 3.3 L 13J5068.3816 Guide Form drill, SL, cortical bone d 3.8 mm L 16 mm d 3.3 L 16J5068.4307 Guide Form drill, SL, cortical bone d 4.3 mm L 7 mm d 4.3 L 7J5068.4309 Guide Form drill, SL, cortical bone d 4.3 mm L 9 mm d 4.3 L 9J5068.4311 Guide Form drill, SL, cortical bone d 4.3 mm L 11 mm d 4.3 L 11J5068.4313 Guide Form drill, SL, cortical bone d 4.3 mm L 13 mm d 4.3 L 13J5068.4316 Guide Form drill, SL, cortical bone d 4.3 mm L 16 mm d 4.3 L 16J5070.3309 Form drill PROGRESSIVE-LINE, d 3.3 mm, L 9J5070.3311 Form drill PROGRESSIVE-LINE, d 3.3 mm, L 11J5070.3313 Form drill PROGRESSIVE-LINE, d 3.3 mm, L 13J5070.3316 Form drill PROGRESSIVE-LINE, d 3.3 mm, L 16J5070.3807 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 7J5070.3809 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 9J5070.3811 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 11J5070.3813 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 13J5070.3816 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 16 | 2005 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | J5417.2800 Pre-Osteotome SCREW-LINE, straight convex d 1.7-2.8 mmJ5418.3300 Osteotome SCREW-LINE, straight convex d 3.3 mmJ5418.3310 Osteotome SCREW-LINE, angled convex d 3.3 mmJ5418.3800 Osteotome SCREW-LINE, straight convex d 3.8 mmJ5418.3810 Osteotome SCREW-LINE, angled convex d 3.8 mmJ5418.4300 Osteotome SCREW-LINE, straight convex d 4.3 mmJ5418.4310 Osteotome SCREW-LINE, angled convex d 4.3 mmJ5418.5000 Osteotome SCREW-LINE, straight convex d 5 mmJ5418.5010 Osteotome SCREW-LINE, angled convex d 5 mmJ5418.6000 Osteotome SCREW-LINE, straight convex d 6 mm 20 moreJ5418.6010 Osteotome SCREW-LINE, angled convex d 6 mmJ5418020 Osteotomy set CAMLOG®/ CONELOG® SCREW-LINE, straight convexJ5418020 Osteotomy set CAMLOG®/ CONELOG® SL, str., convexJ5418030 Osteotomy Set CAMLOG®/ CONELOG® SCREW-LINE, angled convexJ5418030 Osteotomy set CAMLOG®/ CONELOG® SL, ang., convexJ5419.2800 Pre-Osteotome SCREW-LINE, straight concave d 1.7-2.8 mmJ5420.3300 Osteotome SCREW-LINE, straight concave d 3.3 mmJ5420.3310 Osteotome SCREW-LINE, angled concave d 3.3 mmJ5420.3800 Osteotome SCREW-LINE, straight concave d 3.8 mmJ5420.3810 Osteotome SCREW-LINE, angled concave d 3.8 mmJ5420.4300 Osteotome SCREW-LINE, straight concave d 4.3 mmJ5420.4310 Osteotome SCREW-LINE, angled concave d 4.3 mmJ5420.5000 Osteotome SCREW-LINE, straight concave d 5 mmJ5420.5010 Osteotome SCREW-LINE, angled concave d 5 mmJ5420.6000 Osteotome SCREW-LINE, straight concave d 6 mmJ5420.6010 Osteotome SCREW-LINE, angled concave d 6 mmJ5420020 Osteotomy Set CAMLOG®/ CONELOG® SCREW-LINE, straight concaveJ5420020 Osteotomy set CAMLOG®/ CONELOG® SL, str., concaveJ5420030 Osteotomy Set CAMLOG®/ CONELOG® SCREW-LINE, angled concaveJ5420030 Osteotomy set CAMLOG®/ CONELOG® SL, ang., concave | 2005 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2005 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names CAMLOG Biotechnologies GmbH as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Sep 2020 | K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | DZE Root-Form Endosseous Implant |
| 14 Sep 2016 | K160784 | CAM Titanium Blanks | NHA Endosseous Dental Implant Abutment |
| 31 Mar 2016 | K153779 | Abutment for Bridges | NHA Endosseous Dental Implant Abutment |
| 12 Jan 2016 | K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | NHA Endosseous Dental Implant Abutment |
| 2 Oct 2015 | K151599 | iSy Implant System | DZE Root-Form Endosseous Implant |
| 17 Feb 2015 | K143337 | CONELOG Titanium base CAD/CAM | NHA Endosseous Dental Implant Abutment |
| 6 Aug 2014 | K133991 | ISY | DZE Root-Form Endosseous Implant |
| 14 Dec 2012 | K113779 | CONELOG IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Jan 2011 | K103252 | CAMLOG VARIO SR ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 18 Jun 2009 | K090347 | CAMLOG ABUTMENTS PS | NHA Endosseous Dental Implant Abutment |
| 30 Jan 2009 | K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS | DZE Root-Form Endosseous Implant |
| 5 Mar 2008 | K073553 | CAMLOG IMPLANT SYSTEM ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 10 Aug 2007 | K071213 | CAMLOG LOGFIT PROSTHETIC SYSTEM | NHA Endosseous Dental Implant Abutment |
| 17 Feb 2006 | K051636 | CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: Digital Age Dental Laboratories, Ltd. (3).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ALTATEC GMBHFDA reg. 9613866 | WIMSHEIM Baden-Wurttemberg, Germany | Manufacturer |
| CAMLOG Biotechnologies GmbHFDA reg. 3007283751 | Basel Basel-Stadt, Switzerland | Foreign exporter, Specification developer |
Other names on FDA records
ALTATEC GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9071675). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.