| Device Type ID | 1101 |
| Device Name | Saw, Bone, Ac-powered |
| Regulation Description | Bone Cutting Instrument And Accessories. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.4120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DZH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1101 |
| Device | Implant, Endosseous, Root-form |
| Product Code | DZE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endosseous Dental Implant. |
| CFR Regulation Number | 872.4120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
A.B. DENTAL DEVICES, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ACHIMHAI MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ADIN DENTAL IMPLANTS SYSTEMS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AGS MEDIKAL URUNLERI ITH. IHR. TIC. LTD. STI. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALLIANCE GLOBAL TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ALTATEC GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B.T.I. BIOTECHNOLOGY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIO CONCEPT CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIODENTA SWISS AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOGENESIS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOHORIZONS IMPLANT SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET 3I | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOSAF IN S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BLUE SKY BIO, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BONAFIX SURGICAL AND DENTAL IMPLANTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAMLOG BIOTECHNOLOGIES AG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CLINICAL HOUSE EUROPE GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COHO TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORTEX DENTAL IMPLANTS INDUSTRIES LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORTEX DENTAL IMPLANTS INDUSTRIES, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CSM IMPLANT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTACK IMPLANTS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTALPOINT AG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DENTIS CO. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTIS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
DENTIUM CO. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DENTIUM USA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DENTSPLY INTL., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY SIRONA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DIO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
DITRON PRECISION LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EBI INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EST. ANTHOGYR | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GLOBAL DENTAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HAGER & MEISINGER GMBH | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
HIOSSEN INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
IMPLANT DIRECT SYBRON MANUFACTURING, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMPLANT LOGISTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMPLANT MICRODENT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOBIOSURG CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INNOBIOSURG CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTITUT STRAUMANN AG | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
INTRA-LOCK INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JIANGSU TRAUSIM MEDICAL INSTRUMENT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KJ MEDITECH CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KJ MEDITECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
LK CONSULTING GROUP USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDIMECCA CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEGAGEN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MOSTDI INNOVATIONS SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOBIOTECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
NEODENT USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOBEL BIOCARE | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
NOBEL BIOCARE AB | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
NOBELBIOCARE AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NORIS MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
OSSEOFUSE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSTEM IMPLANT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
OSTEOREADY LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRISMATIK | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RITTER DENTAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RITTER IMPLANTS GMBH CO KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SGS INTERNATIONAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHINHUNG MST CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIC INVENT AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOADCO, S.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOUTHERN IMPLANTS (PTY) LTD | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
STRAUMANN | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
STRAUMANN USA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SWEDEN & MARTINA S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
T STRONG, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
T-PLUS IMPLANT TECH. CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TRI DENTAL IMPLANTS INT. AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRINON TITANIUM GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRUABUTMENT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZEST ANCHORS,LLC ALSO DBA ZEST ANCHORS,INC. AND ZEST ANCHORS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZL MICRODENT-ATTACHMENT GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
Z-SYSTEMS AG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZUGA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Osseointegrate | 22042 |
Loss Of Osseointegration | 2893 |
Osseointegration Problem | 2196 |
Adverse Event Without Identified Device Or Use Problem | 1411 |
Fracture | 847 |
Insufficient Information | 332 |
Separation Failure | 189 |
Mechanical Problem | 132 |
Implant, Removal Of | 124 |
Migration Or Expulsion Of Device | 100 |
Device Misassembled During Manufacturing / Shipping | 97 |
Device Damaged By Another Device | 69 |
Implant Mobility NOS (Not Otherwise Specified) | 63 |
Device Appears To Trigger Rejection | 62 |
Packaging Problem | 60 |
Difficult To Position | 59 |
Use Of Device Problem | 58 |
Difficult To Remove | 57 |
Component Missing | 56 |
Difficult To Insert | 51 |
Improper Or Incorrect Procedure Or Method | 48 |
Positioning Problem | 45 |
Detachment Of Device Or Device Component | 37 |
Break | 28 |
Device-Device Incompatibility | 26 |
Patient Device Interaction Problem | 25 |
Device Issue | 25 |
Device Component Or Accessory | 25 |
Patient-Device Incompatibility | 21 |
Unsealed Device Packaging | 18 |
Malposition Of Device | 18 |
Unintended Movement | 15 |
Material Deformation | 14 |
Detachment Of Device Component | 14 |
Device Markings / Labelling Problem | 14 |
Product Quality Problem | 14 |
Positioning Failure | 13 |
Screw | 10 |
No Apparent Adverse Event | 10 |
Off-Label Use | 9 |
Carrier | 8 |
Separation Problem | 8 |
Manufacturing, Packaging Or Shipping Problem | 7 |
Biocompatibility | 7 |
Device Handling Problem | 7 |
Extrusion | 7 |
Inadequacy Of Device Shape And/or Size | 6 |
Device Slipped | 6 |
Crack | 4 |
Missing Value Reason | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Material Fragmentation | 4 |
Mount | 4 |
Failure To Advance | 4 |
Compatibility Problem | 3 |
Defective Component | 3 |
Failure To Adhere Or Bond | 3 |
Contamination During Use | 3 |
Device Operates Differently Than Expected | 3 |
Material Twisted / Bent | 3 |
Difficult Or Delayed Positioning | 3 |
Connection Problem | 3 |
Deformation Due To Compressive Stress | 3 |
Activation, Positioning Or Separation Problem | 3 |
Loosening Of Implant Not Related To Bone-Ingrowth | 3 |
Human Factors Issue | 3 |
Aspiration Issue | 3 |
Scratched Material | 3 |
Defective Device | 2 |
Component Or Accessory Incompatibility | 2 |
Appropriate Term/Code Not Available | 2 |
Failure To Interrogate | 2 |
Human-Device Interface Problem | 2 |
Driver | 2 |
Device Inoperable | 2 |
Material Integrity Problem | 2 |
Screw Tapper | 1 |
Laminate | 1 |
False Alarm | 1 |
Device Operational Issue | 1 |
Contamination / Decontamination Problem | 1 |
Component Misassembled | 1 |
Material Split, Cut Or Torn | 1 |
Difficult Or Delayed Separation | 1 |
Device Difficult To Setup Or Prepare | 1 |
Shipping Damage Or Problem | 1 |
Structural Problem | 1 |
Tip | 1 |
Plate | 1 |
Material Torqued | 1 |
Mechanical Jam | 1 |
Misassembly By Users | 1 |
Inaccurate Information | 1 |
Device Packaging Compromised | 1 |
Incorrect Device Or Component Shipped | 1 |
Sensing Intermittently | 1 |
Dent In Material | 1 |
Folding Issue | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Ejection Problem | 1 |
| Total Device Problems | 31489 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ace Surgical Supply Co., Inc. | II | Apr-17-2017 |
| 2 | Anthogyr | II | Sep-08-2016 |
| 3 | BioHorizons Implant Systems Inc | II | Dec-07-2015 |
| 4 | BioHorizons Implant Systems Inc | II | May-12-2015 |
| 5 | BioHorizons Implant Systems Inc | II | Feb-20-2014 |
| 6 | Biomet 3i, Inc. | III | Jun-25-2015 |
| 7 | Biomet 3i, LLC | II | Mar-29-2017 |
| 8 | Biomet 3i, LLC | II | Sep-19-2016 |
| 9 | Biomet 3i, LLC | II | Aug-12-2016 |
| 10 | Biomet 3i, LLC | II | Jan-06-2016 |
| 11 | Biomet 3i, LLC | II | Apr-10-2015 |
| 12 | Biomet 3i, LLC | II | Apr-15-2014 |
| 13 | Implant Direct Sybron Manufacturing, LLC | II | Jul-26-2018 |
| 14 | Implant Direct Sybron Manufacturing, LLC | II | Jul-05-2018 |
| 15 | Implant Direct Sybron Manufacturing, LLC | II | May-23-2018 |
| 16 | Implant Direct Sybron Manufacturing, LLC | II | May-23-2018 |
| 17 | Implant Direct Sybron Manufacturing, LLC | II | Mar-22-2018 |
| 18 | Implant Direct Sybron Manufacturing, LLC | II | Nov-29-2017 |
| 19 | Implant Direct Sybron Manufacturing, LLC | II | May-22-2017 |
| 20 | Implant Direct Sybron Manufacturing, LLC | II | Jan-28-2017 |
| 21 | Implant Direct Sybron Manufacturing, LLC | II | Jan-09-2017 |
| 22 | Implant Direct Sybron Manufacturing, LLC | II | Aug-02-2016 |
| 23 | Implant Direct Sybron Manufacturing, LLC | II | Mar-28-2016 |
| 24 | Instradent USA, Inc. | II | Dec-22-2014 |
| 25 | Keystone Dental Inc | II | Mar-27-2019 |
| 26 | Keystone Dental Inc | II | Jun-11-2018 |
| 27 | Keystone Dental Inc | II | Apr-24-2018 |
| 28 | Keystone Dental Inc | III | Mar-24-2018 |
| 29 | Keystone Dental Inc | II | Feb-27-2018 |
| 30 | Keystone Dental Inc | II | Feb-26-2018 |
| 31 | Keystone Dental Inc | II | Apr-13-2017 |
| 32 | Keystone Dental Inc | II | Oct-21-2016 |
| 33 | Medtronic Navigation, Inc. | II | Aug-02-2016 |
| 34 | Nobel Biocare Usa Llc | II | Jul-19-2016 |
| 35 | Nobel Biocare Usa Llc | II | Apr-13-2015 |
| 36 | Southern Implants, Inc | II | Mar-12-2015 |
| 37 | Straumann Manufacturing, Inc. | II | Nov-14-2018 |
| 38 | Straumann Manufacturing, Inc. | II | Aug-12-2016 |
| 39 | Straumann USA, LLC | II | Nov-06-2014 |
| 40 | Straumann USA, LLC | II | Oct-23-2014 |
| 41 | Zest Anchors LLC | II | Feb-06-2014 |
| 42 | Zimmer Dental Inc | II | Aug-31-2018 |
| 43 | Zimmer Dental Inc | II | Mar-05-2018 |
| 44 | Zimmer Dental Inc | II | Dec-22-2017 |
| 45 | Zimmer Dental Inc | II | Sep-22-2017 |
| 46 | Zimmer Dental Inc | II | Apr-14-2017 |
| 47 | Zimmer Dental Inc | II | Feb-09-2016 |
| 48 | Zimmer Dental Inc | II | Oct-30-2014 |
| 49 | Zimmer Dental Inc | II | Jan-28-2014 |
| 50 | Zimmer, Inc. | II | Aug-02-2014 |
| 51 | Zimmer, Inc. | II | Jul-14-2014 |